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English — official openFDA product-classification dataset

FDA Product Classification Database — FDA Product Classification Catalogue

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Official catalogue — FDA Product Classification Database

Official openFDA device-classification catalogue containing 7088 product codes, device names, classes, definitions, specialties, and regulation numbers.

Official code: BRT. Product type: Restraint, Patient, Conductive. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6760. Implant flag: N. Life-sustain/support flag: N.

Official code: BRW. Product type: Protector, Dental. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: BRX. Product type: Stool, Anesthesia. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6700. Implant flag: N. Life-sustain/support flag: N.

Official code: BRY. Product type: Cabinet, Table And Tray, Anesthesia. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6100. Implant flag: N. Life-sustain/support flag: N.

Official code: BRZ. Product type: Set, Blood Transfusion. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: BSA. Product type: Warmer, Blood, Electromagnetic Radiation. Official classification: Class III. Official category: Hematology. Regulation number: 864.9205. Implant flag: N. Life-sustain/support flag: N.

Official code: BSB. Product type: Warmer, Blood, Non-Electromagnetic Radiation. Official classification: Class II. Official category: Hematology. Regulation number: 864.9205. Implant flag: N. Life-sustain/support flag: N.

Official code: BSD. Product type: Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: BSE. Product type: Analyzer, Gas, Helium, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: BSF. Product type: Absorber, Carbon-Dioxide. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5310. Implant flag: N. Life-sustain/support flag: N.

Official code: BSI. Product type: Algesimeter, Powered. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1040. Implant flag: N. Life-sustain/support flag: N.

Official code: BSJ. Product type: Mask, Gas, Anesthetic. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: BSK. Product type: Cuff, Tracheal Tube, Inflatable. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5750. Implant flag: N. Life-sustain/support flag: Y.

Official code: BSN. Product type: Filter, Conduction, Anesthetic. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: BSO. Product type: Catheter, Conduction, Anesthetic. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. Implant flag: N. Life-sustain/support flag: N.

Official code: BSP. Product type: Needle, Conduction, Anesthetic (W/Wo Introducer). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: BSR. Product type: Stylet, Tracheal Tube. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5790. Implant flag: N. Life-sustain/support flag: N.

Official code: BSS. Product type: Tube, Nasogastric. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: BST. Product type: Curette, Biopsy, Bronchoscope (Non-Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: BSY. Product type: Catheters, Suction, Tracheobronchial. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6810. Implant flag: N. Life-sustain/support flag: N.

Official code: BSZ. Product type: Gas-Machine, Anesthesia. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5160. Implant flag: N. Life-sustain/support flag: Y.

Official code: BTA. Product type: Pump, Portable, Aspiration (Manual Or Powered). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4780. Implant flag: N. Life-sustain/support flag: N.

Official code: BTB. Product type: Hook, Ether. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: BTC. Product type: Bag, Reservoir. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5320. Implant flag: N. Life-sustain/support flag: N.

Official code: BTG. Product type: Brush, Biopsy, Bronchoscope (Non-Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: BTI. Product type: Compressor, Air, Portable. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.6250. Implant flag: N. Life-sustain/support flag: N.

Official code: BTK. Product type: Strap, Head, Gas Mask. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5560. Implant flag: N. Life-sustain/support flag: N.

Official code: BTL. Product type: Ventilator, Emergency, Powered (Resuscitator). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5925. Implant flag: N. Life-sustain/support flag: Y.

Official code: BTM. Product type: Ventilator, Emergency, Manual (Resuscitator). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5915. Implant flag: N. Life-sustain/support flag: Y.

Official code: BTO. Product type: Tube, Tracheostomy (W/Wo Connector). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5800. Implant flag: N. Life-sustain/support flag: Y.

Official code: BTP. Product type: Dropper, Ether. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: BTQ. Product type: Airway, Nasopharyngeal. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: BTR. Product type: Tube, Tracheal (W/Wo Connector). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5730. Implant flag: N. Life-sustain/support flag: Y.

Official code: BTS. Product type: Tube, Bronchial (W/Wo Connector). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5720. Implant flag: N. Life-sustain/support flag: Y.

Official code: BTT. Product type: Humidifier, Respiratory Gas, (Direct Patient Interface). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5450. Implant flag: N. Life-sustain/support flag: N.

Official code: BTX. Product type: Board, Arm (With Cover), Sterile. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: BTY. Product type: Calculator, Predicted Values, Pulmonary Function. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1890. Implant flag: N. Life-sustain/support flag: N.

Official code: BWA. Product type: Unit, Electrosurgical And Coagulation, With Accessories. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: BWB. Product type: Forceps, Tube Introduction. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5780. Implant flag: N. Life-sustain/support flag: N.

Official code: BWC. Product type: Needle, Emergency Airway. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5090. Implant flag: N. Life-sustain/support flag: Y.

Official code: BWF. Product type: Spirometer, Therapeutic (Incentive). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5690. Implant flag: N. Life-sustain/support flag: N.

Official code: BWH. Product type: Forceps, Biopsy, Bronchoscope (Non-Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: BWJ. Product type: Locator, Acupuncture Point. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5580. Implant flag: N. Life-sustain/support flag: N.

Official code: BWK. Product type: Stimulator, Electro-Acupuncture. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: BWL. Product type: Apparatus, Electronanesthesia. Official classification: Class III. Official category: Anesthesiology. Regulation number: 868.5400. Call for PMAs 12/26/96 (61 FR 50706 (9/27/96)) Implant flag: N. Life-sustain/support flag: N.

Official code: BWN. Product type: Table And Attachments, Operating-Room. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: BWP. Product type: Shoe And Shoe Cover, Conductive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: BXA. Product type: Analyzer, Gas, Water Vapor, Gaseous-Phase. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1975. Implant flag: N. Life-sustain/support flag: N.

Official code: BXB. Product type: Exerciser, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5380. Implant flag: N. Life-sustain/support flag: N.

Official code: BXH. Product type: Gauge, Gas Pressure, Cylinder/Pipeline. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2610. Implant flag: N. Life-sustain/support flag: N.

Official code: BXJ. Product type: Clip, Nose. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6225. Implant flag: N. Life-sustain/support flag: N.

Official code: BXK. Product type: Gas, Calibration (Specified Concentration). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6400. Implant flag: N. Life-sustain/support flag: N.

Official code: BXL. Product type: Algesimeter, Manual. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1030. Implant flag: N. Life-sustain/support flag: N.

Official code: BXM. Product type: Stimulator, Nerve, Ac-Powered. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2775. Implant flag: N. Life-sustain/support flag: N.

Official code: BXN. Product type: Stimulator, Nerve, Battery-Powered. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2775. Implant flag: N. Life-sustain/support flag: N.

Official code: BXO. Product type: Transducer, Gas Pressure. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: BXP. Product type: Transducer, Gas Flow. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2885. Implant flag: N. Life-sustain/support flag: N.

Official code: BXQ. Product type: Rhinoanemometer (Measurement Of Nasal Decongestion). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: BXR. Product type: Meter, Airway Pressure (Inspiratory Force). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1780. Implant flag: N. Life-sustain/support flag: N.

Official code: BXW. Product type: Calibrator, Volume, Gas. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1870. Implant flag: N. Life-sustain/support flag: N.

Official code: BXX. Product type: Calibrator, Pressure, Gas. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2620. Implant flag: N. Life-sustain/support flag: N.

Official code: BXY. Product type: Flowmeter, Calibration, Gas. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2350. Implant flag: N. Life-sustain/support flag: N.

Official code: BYD. Product type: Condenser, Heat And Moisture (Artificial Nose). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5375. Implant flag: N. Life-sustain/support flag: N.

Official code: BYE. Product type: Attachment, Breathing, Positive End Expiratory Pressure. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5965. Implant flag: N. Life-sustain/support flag: Y.

Official code: BYF. Product type: Mask, Oxygen, Low Concentration, Venturi. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5600. Implant flag: N. Life-sustain/support flag: N.

Official code: BYG. Product type: Mask, Oxygen. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5580. Implant flag: N. Life-sustain/support flag: N.

Official code: BYH. Product type: Drain, Tee (Water Trap). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5995. Implant flag: N. Life-sustain/support flag: N.

Official code: BYI. Product type: Percussor, Powered-Electric. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5665. Implant flag: N. Life-sustain/support flag: N.

Official code: BYJ. Product type: Unit, Liquid-Oxygen, Portable. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5655. Implant flag: N. Life-sustain/support flag: N.

Official code: BYK. Product type: Tent, Oxygen, Electrically Powered. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5710. Implant flag: N. Life-sustain/support flag: Y.

Official code: BYL. Product type: Tent, Oxygen. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: BYM. Product type: Tube, Thorpe, Uncompensated. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2320. Implant flag: N. Life-sustain/support flag: N.

Official code: BYN. Product type: Chair, Posture, For Cardiac And Pulmonary Treatment. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5365. Implant flag: N. Life-sustain/support flag: N.

Official code: BYO. Product type: Bottle, Blow. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: BYP. Product type: Mouthpiece, Breathing. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5620. Implant flag: N. Life-sustain/support flag: N.

Official code: BYR. Product type: Transducer, Gas Pressure, Differential. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2875. Implant flag: N. Life-sustain/support flag: N.

Official code: BYS. Product type: Oxygenator, Long Term Support Greater Than 6 Hours. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4100. Implant flag: N. Life-sustain/support flag: Y.

Official code: BYT. Product type: Ventilator, External Body, Negative Pressure, Adult (Cuirass). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5935. Implant flag: N. Life-sustain/support flag: Y.

Official code: BYW. Product type: Device, Rebreathing. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5675. Implant flag: N. Life-sustain/support flag: N.

Official code: BYX. Product type: Tubing, Pressure And Accessories. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5860. Implant flag: N. Life-sustain/support flag: N.

Official code: BYY. Product type: Tube, Aspirating, Flexible, Connecting. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: BYZ. Product type: Trap, Sterile Specimen. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: BZA. Product type: Connector, Airway (Extension). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5810. Implant flag: N. Life-sustain/support flag: N.

Official code: BZB. Product type: Catheter, Nasal, Oxygen. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: BZC. Product type: Calculator, Pulmonary Function Data. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1880. Implant flag: N. Life-sustain/support flag: N.

Official code: BZD. Product type: Ventilator, Non-Continuous (Respirator). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5905. Implant flag: N. Life-sustain/support flag: N.

Official code: BZE. Product type: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5270. Implant flag: N. Life-sustain/support flag: N.

Official code: BZG. Product type: Spirometer, Diagnostic. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1840. Implant flag: N. Life-sustain/support flag: N.

Official code: BZH. Product type: Meter, Peak Flow, Spirometry. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: BZK. Product type: Spirometer, Monitoring (W/Wo Alarm). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: BZL. Product type: Computer, Oxygen-Uptake. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: BZM. Product type: Calculator, Pulmonary Function Interpretor (Diagnostic). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: BZN. Product type: Cart, Emergency, Cardiopulmonary (Excluding Equipment). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6175. Implant flag: N. Life-sustain/support flag: N.

Official code: BZO. Product type: Set, Tubing And Support, Ventilator (W Harness). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5975. Implant flag: N. Life-sustain/support flag: N.

Official code: BZQ. Product type: Monitor, Breathing Frequency. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2375. Implant flag: N. Life-sustain/support flag: N.

Official code: BZR. Product type: Mixer, Breathing Gases, Anesthesia Inhalation. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5330. Implant flag: N. Life-sustain/support flag: Y.

Official code: BZS. Product type: Stethoscope Head. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1930. Implant flag: N. Life-sustain/support flag: N.

Official code: BZT. Product type: Stethoscope, Esophageal, With Electrical Conductors. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1920. Implant flag: N. Life-sustain/support flag: N.

Official code: BZW. Product type: Stethoscope, Esophageal. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1910. Implant flag: N. Life-sustain/support flag: N.

Official code: CAC. Product type: Apparatus, Autotransfusion. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5830. Implant flag: N. Life-sustain/support flag: Y.

Official code: CAD. Product type: Vaporizer, Anesthesia, Non-Heated. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: CAE. Product type: Airway, Oropharyngeal, Anesthesiology. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5110. Implant flag: N. Life-sustain/support flag: N.

Official code: CAF. Product type: Nebulizer (Direct Patient Interface). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5630. Implant flag: N. Life-sustain/support flag: N.

Official code: CAG. Product type: Circulator, Breathing-Circuit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5250. Implant flag: N. Life-sustain/support flag: Y.

Official code: CAH. Product type: Filter, Bacterial, Breathing-Circuit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5260. Implant flag: N. Life-sustain/support flag: N.

Official code: CAI. Product type: Circuit, Breathing (W Connector, Adaptor, Y Piece). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: CAK. Product type: Microfilter, Blood Transfusion. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: CAL. Product type: Laryngoscope, Non-Rigid. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5530. Implant flag: N. Life-sustain/support flag: N.

Official code: CAM. Product type: Yoke Assembly, Medical Gas. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6885. Implant flag: N. Life-sustain/support flag: N.

Official code: CAN. Product type: Regulator, Pressure, Gas Cylinder. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: CAO. Product type: Airway, Esophageal (Obturator). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5650. Implant flag: N. Life-sustain/support flag: Y.

Official code: CAP. Product type: Monitor, Airway Pressure (Includes Gauge And/Or Alarm). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2600. Implant flag: N. Life-sustain/support flag: N.

Official code: CAR. Product type: Monitor, Spinal-Fluid Pressure, Electrically Powered. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2460. Implant flag: N. Life-sustain/support flag: N.

Official code: CAT. Product type: Cannula, Nasal, Oxygen. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5340. Implant flag: N. Life-sustain/support flag: N.

Official code: CAW. Product type: Generator, Oxygen, Portable. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: CAX. Product type: Flowmeter, Tube, Thorpe, Back-Pressure Compensated. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2340. Implant flag: N. Life-sustain/support flag: N.

Official code: CAZ. Product type: Anesthesia Conduction Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5140. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: CBA. Product type: Monitor, Air Embolism, Ultrasonic. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2025. Implant flag: N. Life-sustain/support flag: N.

Official code: CBC. Product type: Bottle, Collection And Trap, Breathing System (Uncalibrated). Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: CBD. Product type: Bottle, Collection, Breathing System (Calibrated). Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: CBF. Product type: Chamber, Hyperbaric. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5470. Implant flag: N. Life-sustain/support flag: Y.

Official code: CBG. Product type: Spreader, Cuff. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5760. Implant flag: N. Life-sustain/support flag: N.

Official code: CBH. Product type: Device, Fixation, Tracheal Tube. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5770. Implant flag: N. Life-sustain/support flag: N.

Official code: CBI. Product type: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5740. Implant flag: N. Life-sustain/support flag: Y.

Official code: CBK. Product type: Ventilator, Continuous, Facility Use. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. Implant flag: N. Life-sustain/support flag: Y.

Official code: CBL. Product type: Absorbent, Carbon-Dioxide. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: CBN. Product type: Apparatus, Gas-Scavenging. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5430. Implant flag: N. Life-sustain/support flag: N.

Official code: CBO. Product type: Attachment, Intermittent Mandatory Ventilation (Imv). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5955. Implant flag: N. Life-sustain/support flag: Y.

Official code: CBP. Product type: Valve, Non-Rebreathing. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5870. Implant flag: N. Life-sustain/support flag: Y.

Official code: CBQ. Product type: Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: CBR. Product type: Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: CBS. Product type: Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: CBT. Product type: Arterial Blood Sampling Kit. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1100. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: CBZ. Product type: Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: CCC. Product type: Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1150. Implant flag: N. Life-sustain/support flag: N.

Official code: CCE. Product type: Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: CCI. Product type: Analyzer, Gas, Nitrogen, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1690. Implant flag: N. Life-sustain/support flag: N.

Official code: CCJ. Product type: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1430. Implant flag: N. Life-sustain/support flag: N.

Official code: CCK. Product type: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1400. Implant flag: N. Life-sustain/support flag: N.

Official code: CCL. Product type: Analyzer, Gas, Oxygen, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1720. Implant flag: N. Life-sustain/support flag: N.

Official code: CCM. Product type: Plethysmograph, Pressure. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1750. Implant flag: N. Life-sustain/support flag: N.

Official code: CCN. Product type: Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2300. Implant flag: N. Life-sustain/support flag: N.

Official code: CCO. Product type: Bed, Rocking, Breathing Assist. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5180. Implant flag: N. Life-sustain/support flag: Y.

Official code: CCQ. Product type: Nebulizer, Medicinal, Non-Ventilatory (Atomizer). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5640. Implant flag: N. Life-sustain/support flag: N.

Official code: CCT. Product type: Applicator (Laryngo-Tracheal), Topical Anesthesia. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5170. Implant flag: N. Life-sustain/support flag: N.

Official code: CCW. Product type: Laryngoscope, Rigid. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: CCX. Product type: Support, Patient Position. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6820. Implant flag: N. Life-sustain/support flag: N.

Official code: CCY. Product type: Zimmerman (Spectrophotometric), 17-Ketosteroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1430. Implant flag: N. Life-sustain/support flag: N.

Official code: CCZ. Product type: Zimmerman/Norymberski, 17-Ketogenic Steroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: CDA. Product type: Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1390. Implant flag: N. Life-sustain/support flag: N.

Official code: CDB. Product type: Porter Silber Hydrazone, 17-Hydroxycorticosteroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: CDC. Product type: L-Leucyl B-Naphthylamide, Leucine Aminopeptidase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1460. Implant flag: N. Life-sustain/support flag: N.

Official code: CDD. Product type: Radioassay, Vitamin B12. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: CDE. Product type: Chromatographic Separation/Zimmerman, 17-Ketosteroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1430. Implant flag: N. Life-sustain/support flag: N.

Official code: CDF. Product type: Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1795. Implant flag: N. Life-sustain/support flag: N.

Official code: CDG. Product type: Chromatography Separation/Zimmerman 17-Ketogenic Steroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: CDH. Product type: Acid, Uric, Phosphotungstate Reduction. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. Implant flag: N. Life-sustain/support flag: N.

Official code: CDK. Product type: Acid, Vanilmandelic, Electrophoretic Separation. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1795. Implant flag: N. Life-sustain/support flag: N.

Official code: CDL. Product type: Berthelot Indophenol, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: CDM. Product type: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1785. Implant flag: N. Life-sustain/support flag: N.

Official code: CDN. Product type: Urease, Photometric, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: CDO. Product type: Acid, Uric, Uricase (U.V.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. Implant flag: N. Life-sustain/support flag: N.

Official code: CDP. Product type: Radioimmunoassay, Total Triiodothyronine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1710. Implant flag: N. Life-sustain/support flag: N.

Official code: CDQ. Product type: Urease And Glutamic Dehydrogenase, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: CDR. Product type: 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: CDS. Product type: Electrode, Ion Specific, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: CDT. Product type: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1705. Implant flag: N. Life-sustain/support flag: N.

Official code: CDW. Product type: Diacetyl-Monoxime, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: CDX. Product type: Radioimmunoassay, Total Thyroxine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: CDZ. Product type: Radioimmunoassay, Testosterones And Dihydrotestosterone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1680. Implant flag: N. Life-sustain/support flag: N.

Official code: CEA. Product type: Tlc Chromatographic Separation Triglycerides. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1705. Implant flag: N. Life-sustain/support flag: N.

Official code: CEC. Product type: Radioimmunoassay, Free Thyroxine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1695. Implant flag: N. Life-sustain/support flag: N.

Official code: CED. Product type: 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1520. Implant flag: N. Life-sustain/support flag: N.

Official code: CEE. Product type: Radioimmunoassay, Thyroxine-Binding Globulin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1685. Implant flag: N. Life-sustain/support flag: N.

Official code: CEF. Product type: Electrophoretic, Protein Fractionation. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: CEI. Product type: Uranyl Acetate/Zinc Acetate, Sodium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1665. Implant flag: N. Life-sustain/support flag: N.

Official code: CEJ. Product type: Tetraphenyl Borate, Colorimetry, Potassium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: CEK. Product type: Biuret (Colorimetric), Total Protein. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1635. Implant flag: N. Life-sustain/support flag: N.

Official code: CEL. Product type: Ammonium Molybdate And Ammonium Vanadate, Phospholipids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1575. Implant flag: N. Life-sustain/support flag: N.

Official code: CEM. Product type: Electrode, Ion Specific, Potassium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: CEN. Product type: Dye-Indicator, Ph (Urinary, Non-Quantitative). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1550. Implant flag: N. Life-sustain/support flag: N.

Official code: CEO. Product type: Phosphomolybdate (Colorimetric), Inorganic Phosphorus. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1580. Implant flag: N. Life-sustain/support flag: N.

Official code: CEP. Product type: Radioimmunoassay, Luteinizing Hormone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1485. Implant flag: N. Life-sustain/support flag: N.

Official code: CEQ. Product type: Molybdenum Blue Method, Phospholipids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1575. Implant flag: N. Life-sustain/support flag: N.

Official code: CER. Product type: 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1440. Implant flag: N. Life-sustain/support flag: N.

Official code: CES. Product type: Chromogenesis, Phenylketones (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1560. Implant flag: N. Life-sustain/support flag: N.

Official code: CET. Product type: Olive Oil Emulsion (Turbidimetric), Lipase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1465. Implant flag: N. Life-sustain/support flag: N.

Official code: CEW. Product type: Radioimmunoassay, Parathyroid Hormone. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1545. Implant flag: N. Life-sustain/support flag: N.

Official code: CEX. Product type: Chromatographic Separation, Lactate Dehydrogenase Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1445. Implant flag: N. Life-sustain/support flag: N.

Official code: CFA. Product type: Electrode, Ion Specific, Magnesium. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1495. Implant flag: N. Life-sustain/support flag: N.

Official code: CFB. Product type: Chromatographic Derivative, Total Lipids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1470. Implant flag: N. Life-sustain/support flag: N.

Official code: CFD. Product type: Sulfophosphovanillin, Colorimetry, Total Lipids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1470. Implant flag: N. Life-sustain/support flag: N.

Official code: CFE. Product type: Electrophoretic, Lactate Dehydrogenase Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1445. Implant flag: N. Life-sustain/support flag: N.

Official code: CFF. Product type: Immunoelectrophoretic, Immunoglobulins, (G, A, M). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CFG. Product type: Oil Emulsion/Thymolphthalein (Titrimetric), Lipase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1465. Implant flag: N. Life-sustain/support flag: N.

Official code: CFH. Product type: Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1440. Implant flag: N. Life-sustain/support flag: N.

Official code: CFJ. Product type: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1440. Implant flag: N. Life-sustain/support flag: N.

Official code: CFL. Product type: Radioimmunoassay, Human Growth Hormone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1370. Implant flag: N. Life-sustain/support flag: N.

Official code: CFM. Product type: Bathophenanthroline, Colorimetry, Iron (Non-Heme). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: CFN. Product type: Method, Nephelometric, Immunoglobulins (G, A, M). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CFO. Product type: Titrimetric, Magnesium. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1495. Implant flag: N. Life-sustain/support flag: N.

Official code: CFP. Product type: Radioimmunoassay, Immunoreactive Insulin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1405. Implant flag: N. Life-sustain/support flag: N.

Official code: CFQ. Product type: Radioimmunoassay, Immunoglobulins (G, A, M). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CFR. Product type: Hexokinase, Glucose. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: CFT. Product type: Radioimmunoassay, Prolactin (Lactogen). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1625. Implant flag: N. Life-sustain/support flag: N.

Official code: CFW. Product type: Copper Reduction, Glucose. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: CGA. Product type: Glucose Oxidase, Glucose. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: CGC. Product type: Radioimmunoassay, Gastrin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1325. Implant flag: N. Life-sustain/support flag: N.

Official code: CGD. Product type: Ferricyanide, Glucose. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: CGE. Product type: Orthotoluidine, Glucose. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: CGF. Product type: Radioimmunoassay, Estrone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1280. Implant flag: N. Life-sustain/support flag: N.

Official code: CGH. Product type: Electrophoretic, Globulin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: CGI. Product type: Radioimmunoassay, Estriol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1265. Implant flag: N. Life-sustain/support flag: N.

Official code: CGJ. Product type: Radioimmunoassay, Follicle-Stimulating Hormone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: CGL. Product type: Electrode, Ion Based, Enzymatic, Creatinine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1225. Implant flag: N. Life-sustain/support flag: N.

Official code: CGM. Product type: Method, Immunodiffusion, Immunoglobulins (G, A, M). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CGN. Product type: Acid, Folic, Radioimmunoassay. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1295. Implant flag: N. Life-sustain/support flag: N.

Official code: CGO. Product type: Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: CGR. Product type: Radioimmunoassay, Cortisol. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1205. Implant flag: N. Life-sustain/support flag: N.

Official code: CGS. Product type: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: CGT. Product type: Radioimmunoassay, Cyclic Gmp. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1230. Implant flag: N. Life-sustain/support flag: N.

Official code: CGX. Product type: Alkaline Picrate, Colorimetry, Creatinine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1225. Implant flag: N. Life-sustain/support flag: N.

Official code: CGZ. Product type: Electrode, Ion-Specific, Chloride. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: CHA. Product type: Radioimmunoassay, Corticosterone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: CHC. Product type: Titrimetric Permanganate And Bromophenol Blue, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CHD. Product type: Acid, Ferric Ion-Sulfuric, Cholesterol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: CHE. Product type: Radioimmunoassay, Corticoids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1195. Implant flag: N. Life-sustain/support flag: N.

Official code: CHG. Product type: Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: CHH. Product type: Enzymatic Esterase--Oxidase, Cholesterol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: CHI. Product type: Lipase-Esterase, Enzymatic, Photometric, Lipase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1465. Implant flag: N. Life-sustain/support flag: N.

Official code: CHJ. Product type: Mercuric Thiocyanate, Colorimetry, Chloride. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: CHK. Product type: Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: CHL. Product type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1120. Implant flag: N. Life-sustain/support flag: N.

Official code: CHM. Product type: Radioimmunoassay, Total Estrogens In Pregnancy. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1270. Implant flag: N. Life-sustain/support flag: N.

Official code: CHN. Product type: Immunochemical, Ceruloplasmin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: CHO. Product type: Radioimmunoassay, Cyclic Amp. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1230. Implant flag: N. Life-sustain/support flag: N.

Official code: CHP. Product type: Radioimmunoassay, Estradiol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1260. Implant flag: N. Life-sustain/support flag: N.

Official code: CHQ. Product type: Chromatographic/Fluorometric Method, Catecholamines. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1165. Implant flag: N. Life-sustain/support flag: N.

Official code: CHR. Product type: Titrimetric Phenol Red, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: CHS. Product type: Coulometric Method, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: CHT. Product type: Electrophoretic Method, Catecholamines. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1165. Implant flag: N. Life-sustain/support flag: N.

Official code: CHW. Product type: Titrimetric With Edta And Indicator, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CHZ. Product type: Di (O-Hydroxyphenylimine) Ethane, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CIA. Product type: Methylthymol Blue, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CIB. Product type: Radioimmunoassay, Angiotensin I And Renin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1085. Implant flag: N. Life-sustain/support flag: N.

Official code: CIC. Product type: Cresolphthalein Complexone, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CID. Product type: Alizarin Sulfonate, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CIE. Product type: Volumetric/Manometric, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: CIF. Product type: Vanillin Pyruvate, Ast/Sgot. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: CIG. Product type: Diazo Colorimetry, Bilirubin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1110. Implant flag: N. Life-sustain/support flag: N.

Official code: CIJ. Product type: Saccharogenic, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: CIK. Product type: Radial Diffusion, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: CIL. Product type: Cresol Red Colorimetry, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: CIN. Product type: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CIO. Product type: Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CIQ. Product type: Diazo, Ast/Sgot. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: CIS. Product type: Hydrazone Colorimetry, Ast/Sgot. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: CIT. Product type: Nadh Oxidation/Nad Reduction, Ast/Sgot. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: CIW. Product type: Starch-Dye Bound Polymer, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: CIX. Product type: Bromcresol Green Dye-Binding, Albumin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1035. Implant flag: N. Life-sustain/support flag: N.

Official code: CIY. Product type: Radioimmunoassay, Androsterone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1080. Implant flag: N. Life-sustain/support flag: N.

Official code: CIZ. Product type: Radioimmunoassay, Androstenedione. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: CJA. Product type: Amyloclastic, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: CJB. Product type: Chromatographic Separation/Radioimmunoassay, Aldosterone. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1045. Implant flag: N. Life-sustain/support flag: N.

Official code: CJC. Product type: Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1040. Implant flag: N. Life-sustain/support flag: N.

Official code: CJD. Product type: Nitrosalicylate Reduction, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: CJE. Product type: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CJF. Product type: Tetrabromophenolphthalein, Albumin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1035. Implant flag: N. Life-sustain/support flag: N.

Official code: CJG. Product type: Tetrabromo-M-Cresolsulfonphthalein, Albumin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1035. Implant flag: N. Life-sustain/support flag: N.

Official code: CJH. Product type: Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CJI. Product type: Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CJJ. Product type: Diazo, Alt/Sgpt. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1030. Implant flag: N. Life-sustain/support flag: N.

Official code: CJK. Product type: Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CJL. Product type: Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CJM. Product type: Radioimmunoassay, Aldosterone. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1045. Implant flag: N. Life-sustain/support flag: N.

Official code: CJN. Product type: Acid Phosphatase, Nitrophenylphosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: CJO. Product type: Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CJQ. Product type: Radial Immunodiffusion, Albumin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1035. Implant flag: N. Life-sustain/support flag: N.

Official code: CJR. Product type: Acid Phosphatase, Thymol Blue Monophosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: CJT. Product type: Hydrazone Colorimetry, Aldolase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1040. Implant flag: N. Life-sustain/support flag: N.

Official code: CJW. Product type: Bromcresol Purple Dye-Binding, Albumin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1035. Implant flag: N. Life-sustain/support flag: N.

Official code: CJX. Product type: Acid Phosphatase, Disodium Phenylphosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: CJY. Product type: Azo Dye, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: CJZ. Product type: Acid, Hydroxyazobenzene-Benzoic, Albumin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1035. Implant flag: N. Life-sustain/support flag: N.

Official code: CKA. Product type: Nadh Oxidation/Nad Reduction, Alt/Sgpt. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1030. Implant flag: N. Life-sustain/support flag: N.

Official code: CKB. Product type: Acid Phosphatase, Naphthyl Phosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: CKC. Product type: Vanillin Pyruvate, Alt/Sgpt. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1030. Implant flag: N. Life-sustain/support flag: N.

Official code: CKD. Product type: Hydrazone Colorimetry, Alt/Sgpt. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1030. Implant flag: N. Life-sustain/support flag: N.

Official code: CKE. Product type: Acid Phosphatase, Thymolphthale Inmonophosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: CKF. Product type: Phenylphosphate, Alkaline Phosphatase Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: CKG. Product type: Radioimmunoassay, Acth. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1025. Implant flag: N. Life-sustain/support flag: N.

Official code: CKH. Product type: Acid Phosphatase, Beta Glycerophosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: CZJ. Product type: Igd, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CZK. Product type: Iga, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CZL. Product type: Iga, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CZM. Product type: Iga, Ferritin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CZN. Product type: Iga, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CZO. Product type: Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: CZP. Product type: Iga, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: CZQ. Product type: Bence-Jones Protein, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: CZR. Product type: Hemopexin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5490. Implant flag: N. Life-sustain/support flag: N.

Official code: CZS. Product type: Retinol-Binding Protein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5765. Implant flag: N. Life-sustain/support flag: N.

Official code: CZT. Product type: Hemopexin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5490. Implant flag: N. Life-sustain/support flag: N.

Official code: CZW. Product type: Complement C3, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: CZX. Product type: Hemopexin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5490. Implant flag: N. Life-sustain/support flag: N.

Official code: CZY. Product type: Complement C1s, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: CZZ. Product type: Haptoglobin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5460. Implant flag: N. Life-sustain/support flag: N.

Official code: DAA. Product type: Igg, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DAB. Product type: Haptoglobin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5460. Implant flag: N. Life-sustain/support flag: N.

Official code: DAC. Product type: Complement C3b Activator, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5260. Implant flag: N. Life-sustain/support flag: N.

Official code: DAD. Product type: Haptoglobin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5460. Implant flag: N. Life-sustain/support flag: N.

Official code: DAE. Product type: Complement C9, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: DAF. Product type: Gamma Globulin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DAG. Product type: Complement C8, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: DAH. Product type: Gamma Globulin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DAI. Product type: Complement C1r, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: DAJ. Product type: Free Secretory Component, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5380. Implant flag: N. Life-sustain/support flag: N.

Official code: DAK. Product type: Complement C1q, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: DAL. Product type: Fraction Iv-5, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5360. Implant flag: N. Life-sustain/support flag: N.

Official code: DAM. Product type: Hemoglobin, Chain Specific, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5470. Implant flag: N. Life-sustain/support flag: N.

Official code: DAN. Product type: Fibrinopeptide A, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: DAO. Product type: Igm (Mu Chain Specific), Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DAP. Product type: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7320. Implant flag: N. Life-sustain/support flag: N.

Official code: DAQ. Product type: Igg (Fd Fragment Specific), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: DAR. Product type: Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: DAS. Product type: Igg (Fc Fragment Specific), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5530. Implant flag: N. Life-sustain/support flag: N.

Official code: DAT. Product type: Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: DAW. Product type: Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: DAX. Product type: Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: DAY. Product type: Complement C5, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: DAZ. Product type: Fibrinogen And Split Products, Antigen, Antiserum, Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: DBA. Product type: Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: DBC. Product type: Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: DBE. Product type: Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5120. Implant flag: N. Life-sustain/support flag: N.

Official code: DBF. Product type: Ferritin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5340. Implant flag: N. Life-sustain/support flag: N.

Official code: DBH. Product type: Fc, Rhodamine, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5530. Implant flag: N. Life-sustain/support flag: N.

Official code: DBI. Product type: Complement C4, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: DBJ. Product type: Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5110. Implant flag: N. Life-sustain/support flag: N.

Official code: DBK. Product type: Fc, Fitc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5530. Implant flag: N. Life-sustain/support flag: N.

Official code: DBL. Product type: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: DBM. Product type: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: DBN. Product type: Fc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5530. Implant flag: N. Life-sustain/support flag: N.

Official code: DBT. Product type: Factor Xiii A, S, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5330. Implant flag: N. Life-sustain/support flag: N.

Official code: DBY. Product type: Fab, Rhodamine, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: DCB. Product type: Fab, Fitc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: DCE. Product type: Fab, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: DCF. Product type: Albumin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5040. Implant flag: N. Life-sustain/support flag: N.

Official code: DCH. Product type: System, Test, C-Reactive Protein, Rhodamine. Official classification: Class II. Official category: Immunology. Regulation number: 866.5270. Implant flag: N. Life-sustain/support flag: N.

Official code: DCJ. Product type: Beta-Globulin, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: DCK. Product type: C-Reactive Protein, Antigen, Antiserum, And Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5270. Implant flag: N. Life-sustain/support flag: N.

Official code: DCN. Product type: System, Test, C-Reactive Protein. Official classification: Class II. Official category: Immunology. Regulation number: 866.5270. Implant flag: N. Life-sustain/support flag: N.

Official code: DCO. Product type: Alpha-Globulin, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: DCT. Product type: Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: DCY. Product type: Ceruloplasmin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: DDB. Product type: Ceruloplasmin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: DDC. Product type: Thyroglobulin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: DDD. Product type: Transferrin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: DDE. Product type: Carbonic Anhydrase C, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: DDF. Product type: Prothrombin, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5735. Implant flag: N. Life-sustain/support flag: N.

Official code: DDG. Product type: Transferrin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: DDH. Product type: Carbonic Anhydrase B, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: DDI. Product type: Transferrin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: DDJ. Product type: Thyroglobulin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: DDK. Product type: Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: DDL. Product type: Thyroglobulin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: DDN. Product type: Beta-2-Glycoprotein I, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5430. Implant flag: N. Life-sustain/support flag: N.

Official code: DDO. Product type: Myoglobin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5680. Implant flag: N. Life-sustain/support flag: N.

Official code: DDQ. Product type: Antigen, Antiserum, Control, Antithrombin Iii. Official classification: Class II. Official category: Hematology. Regulation number: 864.7060. Implant flag: N. Life-sustain/support flag: N.

Official code: DDR. Product type: Myoglobin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5680. Implant flag: N. Life-sustain/support flag: N.

Official code: DDS. Product type: Prealbumin, Fitc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5060. Implant flag: N. Life-sustain/support flag: N.

Official code: DDT. Product type: Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5620. Implant flag: N. Life-sustain/support flag: N.

Official code: DDX. Product type: Plasminogen, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5715. Implant flag: N. Life-sustain/support flag: N.

Official code: DDY. Product type: Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5620. Implant flag: N. Life-sustain/support flag: N.

Official code: DDZ. Product type: Albumin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5040. Implant flag: N. Life-sustain/support flag: N.

Official code: DEA. Product type: Myoglobin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5680. Implant flag: N. Life-sustain/support flag: N.

Official code: DEB. Product type: Alpha-2-Macroglobulin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5620. Implant flag: N. Life-sustain/support flag: N.

Official code: DEC. Product type: Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: DEF. Product type: Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: DEG. Product type: Lactoferrin, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: DEH. Product type: Lambda, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DEI. Product type: Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: DEJ. Product type: Alpha-2-Glycoproteins, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: DEK. Product type: Kappa, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DEL. Product type: Lipoprotein X, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5590. Implant flag: N. Life-sustain/support flag: N.

Official code: DEM. Product type: Alpha-1-Antitrypsin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: DEN. Product type: Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: DEO. Product type: Kappa, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DEP. Product type: Lambda, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DER. Product type: Alpha-1-Lipoprotein, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5580. Implant flag: N. Life-sustain/support flag: N.

Official code: DES. Product type: Lambda, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DET. Product type: Lactic Dehydrogenase, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5560. Implant flag: N. Life-sustain/support flag: N.

Official code: DEW. Product type: Igg, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DEX. Product type: Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: DEY. Product type: Igm, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DEZ. Product type: Igm, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFB. Product type: Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: DFC. Product type: Lipoprotein, Low-Density, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5600. Implant flag: N. Life-sustain/support flag: N.

Official code: DFD. Product type: Kappa, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFF. Product type: Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5080. Implant flag: N. Life-sustain/support flag: N.

Official code: DFG. Product type: Lambda, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFH. Product type: Kappa, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFI. Product type: Total Spinal-Fluid, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5860. Implant flag: N. Life-sustain/support flag: N.

Official code: DFJ. Product type: Albumin, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5040. Implant flag: N. Life-sustain/support flag: N.

Official code: DFK. Product type: Igg (Fab Fragment Specific), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: DFL. Product type: Igm, Ferritin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFM. Product type: Ige, Ferritin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DFO. Product type: Igg, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DFQ. Product type: Sperm, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: DFS. Product type: Igm, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFT. Product type: Igm, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: DFX. Product type: Sperm, Fitc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: DFZ. Product type: Igg (Gamma Chain Specific), Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGA. Product type: Cohn Fraction Ii, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: DGB. Product type: Seminal Fluid, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: DGC. Product type: Ige, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGD. Product type: Igg, Ferritin, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGE. Product type: Igd, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGG. Product type: Igd, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGH. Product type: Igd, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGI. Product type: Breast Milk, Rhodamine, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5170. Implant flag: N. Life-sustain/support flag: N.

Official code: DGJ. Product type: Colostrum, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5230. Implant flag: N. Life-sustain/support flag: N.

Official code: DGK. Product type: Igg, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGL. Product type: Ige, Rhodamine, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGM. Product type: Breast Milk, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5170. Implant flag: N. Life-sustain/support flag: N.

Official code: DGN. Product type: Breast Milk, Fitc, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5170. Implant flag: N. Life-sustain/support flag: N.

Official code: DGO. Product type: Ige, Peroxidase, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGP. Product type: Ige, Fitc, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: DGQ. Product type: Whole Blood Plasma, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: DGR. Product type: Whole Human Serum, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: DGW. Product type: System, Test, Hypersensitivity Pneumonitis. Official classification: Class II. Official category: Immunology. Regulation number: 866.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: DGX. Product type: Ng1m(A), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5065. Implant flag: N. Life-sustain/support flag: N.

Official code: DHA. Product type: System, Test, Human Chorionic Gonadotropin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1155. Implant flag: N. Life-sustain/support flag: N.

Official code: DHB. Product type: System, Test, Radioallergosorbent (Rast) Immunological. Official classification: Class II. Official category: Immunology. Regulation number: 866.5750. Implant flag: N. Life-sustain/support flag: N.

Official code: DHC. Product type: System, Test, Systemic Lupus Erythematosus. Official classification: Class II. Official category: Immunology. Regulation number: 866.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: DHF. Product type: D/Km-1, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5065. Implant flag: N. Life-sustain/support flag: N.

Official code: DHI. Product type: Ng3m(Bo), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5065. Implant flag: N. Life-sustain/support flag: N.

Official code: DHL. Product type: Protein, Complement, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: DHN. Product type: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: DHQ. Product type: Ng3m(G), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5065. Implant flag: N. Life-sustain/support flag: N.

Official code: DHR. Product type: System, Test, Rheumatoid Factor. Official classification: Class II. Official category: Immunology. Regulation number: 866.5775. Implant flag: N. Life-sustain/support flag: N.

Official code: DHX. Product type: System, Test, Carcinoembryonic Antigen. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: DHY. Product type: Ng4m(A), Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5065. Implant flag: N. Life-sustain/support flag: N.

Official code: DIC. Product type: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DID. Product type: Bacillus Subtilis Microbiology Assay, Tobramycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: DIE. Product type: Heavy Metals Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: DIF. Product type: Drug Mixture Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: DIG. Product type: Cholinesterase Test Paper. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: DIH. Product type: Colorimetry, Cholinesterase. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: DII. Product type: Columns, Glc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: DIJ. Product type: Lead, Delta Amino Levulinic Acid. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: DIK. Product type: Thin Layer Chromatography, Quinine. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: DIL. Product type: Radioimmunoassay, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: DIM. Product type: Gas Chromatography, Salicylate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: DIN. Product type: Gas Chromatography, Cocaine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DIO. Product type: Enzyme Immunoassay, Cocaine And Cocaine Metabolites. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DIP. Product type: Enzyme Immunoassay, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: DIQ. Product type: Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DIR. Product type: Free Radical Assay, Cocaine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DIS. Product type: Enzyme Immunoassay, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: DIT. Product type: Thin Layer Chromatography, Amphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DIW. Product type: Hemagglutination Inhibition, Methadone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: DIX. Product type: Thin Layer Chromatography, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: DIY. Product type: Gas Chromatography, Ethosuximide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: DIZ. Product type: Delayed Analysis, Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DJA. Product type: Column Supports, Glc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: DJB. Product type: Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: DJC. Product type: Thin Layer Chromatography, Methamphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3610. Implant flag: N. Life-sustain/support flag: N.

Official code: DJD. Product type: Enzyme Immunoassay, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: DJE. Product type: Thin Layer Chromatography, Salicylate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: DJF. Product type: Gas Chromatography, Opiates. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: DJG. Product type: Enzyme Immunoassay, Opiates. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: DJH. Product type: Gas Chromatography, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: DJI. Product type: Antiserum, Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: DJJ. Product type: Fluorometry, Morphine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DJK. Product type: Digitoxin Control Serum, Ria. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: DJL. Product type: Free Radical Assay, Amphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DJN. Product type: Mercury Dithiazone, Colorimetry, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: DJO. Product type: Indicator, Cellulose Fluorescent, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DJP. Product type: Radioimmunoassay, Amphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DJQ. Product type: Test Reagents For Phenothiazine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3670. Implant flag: N. Life-sustain/support flag: N.

Official code: DJR. Product type: Enzyme Immunoassay, Methadone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: DJS. Product type: U.V. Light, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DJX. Product type: Radioimmunoassay, Ethosuximide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: DJY. Product type: Ion-Exchange Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2230. Implant flag: N. Life-sustain/support flag: N.

Official code: DJZ. Product type: Devices, Breath Trapping, Alcohol. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3050. Implant flag: N. Life-sustain/support flag: N.

Official code: DKA. Product type: Antiserum, Digoxin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DKB. Product type: Calibrators, Drug Mixture. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: DKC. Product type: Alcohol Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: DKD. Product type: Bacillus Subtilis, Microbiological Assay, Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: DKE. Product type: Reagents, Test, Tetrahydrocannabinol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: DKG. Product type: Plate, Cellulose, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DKH. Product type: Gas Chromatography, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: DKJ. Product type: Colorimetry, Salicylate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: DKK. Product type: Tanks, Developing, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DKN. Product type: Radioimmunoassay, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: DKO. Product type: Adsorbents, Ion-Exchange. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2230. Implant flag: N. Life-sustain/support flag: N.

Official code: DKP. Product type: Radioimmunoassay, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: DKQ. Product type: Antiserum, Digitoxin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DKR. Product type: Thin Layer Chromatography, Methadone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: DKS. Product type: Plate, Silica Gel, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DKT. Product type: Free Radical Assay, Opiates. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: DKW. Product type: Test Reagents For Sulphanimide Derivatives. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: DKX. Product type: Thin Layer Chromatography, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: DKY. Product type: Indicator, Alumina Fluorescent, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DKZ. Product type: Enzyme Immunoassay, Amphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DLA. Product type: Test Reagents For Methyl Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DLB. Product type: Radioimmunoassay, Lsd (125-I). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3580. Implant flag: N. Life-sustain/support flag: N.

Official code: DLC. Product type: Atomizer, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DLD. Product type: Thin Layer Chromatography, Codeine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3270. Implant flag: N. Life-sustain/support flag: N.

Official code: DLE. Product type: Reagents, Test, Bromides. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: DLF. Product type: Enzyme Immunoassay, Ethosuximide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: DLG. Product type: Coating, Liquid, Glc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: DLH. Product type: Gas Chromatography, Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DLI. Product type: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: DLJ. Product type: Calibrators, Drug Specific. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: DLN. Product type: Hemagglutination, Cocaine Metabolites (Benzoylecgnonine). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DLO. Product type: Indicator, Silica Gel Fluorescent, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DLP. Product type: Radioimmunoassay, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: DLR. Product type: Hemagglutination Inhibition, Morphine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DLS. Product type: Gas Chromatograph, Alcohol (Dedicated Instruments). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DLT. Product type: Hemagglutination, Opiates. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: DLX. Product type: Hemagglutination Inhibition, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: DLY. Product type: Plate, Alumina, Tlc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DLZ. Product type: Enzyme Immunoassay, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: DMB. Product type: Gas Chromatography, Methadone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: DMF. Product type: Gas Liquid Chromatography, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: DMG. Product type: Papers, Ion. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2230. Implant flag: N. Life-sustain/support flag: N.

Official code: DMI. Product type: Potassium Dichromate Specific Reagent For Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DMJ. Product type: Test Reagents For Ethyl Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DMK. Product type: Lead, Protoporphyrin, Fluorometric. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: DML. Product type: Nad-Nadh, Specific Reagent For Alcohol Enzyme Method. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DMN. Product type: Thin Layer Chromatography, Cocaine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DMP. Product type: Digoxin Control Serum, Ria. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: DMQ. Product type: Gas Chromatography, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: DMR. Product type: Solution, M-Nitrophenol, Specific Reagent For Cholinesterase. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: DMS. Product type: Gases, Glc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: DMT. Product type: Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DMX. Product type: Liquid Chromatography, Salicylate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: DMY. Product type: Gas Chromatography, Morphine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DMZ. Product type: Liquid Chromatography, Adsorbent. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: DNA. Product type: Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DNC. Product type: Strip, Paper, Salicylate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: DND. Product type: Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DNE. Product type: Atomic Absorption, Antimony. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: DNF. Product type: Liquid Chromatography, Ethosuximide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: DNG. Product type: Free Radical, Benzoylecgnonine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DNH. Product type: Resins, Ion-Exchange, Liquid Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: DNI. Product type: Liquid Chromatography, Amphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DNJ. Product type: Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DNK. Product type: Thin Layer Chromatography, Morphine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DNL. Product type: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DNN. Product type: Calibrators, Ethyl Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: DNO. Product type: Hemagglutination Inhibition, Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: DNP. Product type: Thin Layer Chromatography, Ethosuximide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: DNQ. Product type: Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DNS. Product type: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DNT. Product type: Liquid Chromatography, Methadone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: DNW. Product type: Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DNX. Product type: Lead, Protoporphyrin Zinc Method, Fluorometric. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: DNZ. Product type: Atomic Absorption, Arsenic. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: DOA. Product type: Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DOB. Product type: Radioimmunoassay, Digitoxin (3-H). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DOD. Product type: Gas Chromatography, Amphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DOE. Product type: Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DOF. Product type: Lead, Atomic Absorption. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: DOG. Product type: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DOH. Product type: Electrometry, Cholinesterase. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: DOJ. Product type: Potassium Dichromate, Alcohol. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: DOK. Product type: Free Radical Assay, Morphine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DOL. Product type: Free Radical Assay, Lsd. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3580. Implant flag: N. Life-sustain/support flag: N.

Official code: DOM. Product type: Thin Layer Chromatography, Benzoylecgnonine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: DON. Product type: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DOO. Product type: Liquid Chromatography, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: DOP. Product type: Mass Spectrometer, Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2860. Implant flag: N. Life-sustain/support flag: N.

Official code: DOR. Product type: Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DOS. Product type: Thin Layer Chromatography, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: DOW. Product type: Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DOX. Product type: Fluorometer, Lead (Dedicated Instruments). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: DOY. Product type: Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DOZ. Product type: Liquid Chromatography, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: DPA. Product type: Apparatus, General Use, Thin Layer Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: DPB. Product type: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DPD. Product type: Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DPE. Product type: Thin Layer Chromatography, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: DPG. Product type: Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DPH. Product type: Mercury, Atomic Absorption. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: DPI. Product type: Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DPJ. Product type: Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: DPK. Product type: Liquid Chromatography, Morphine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: DPL. Product type: Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: DPM. Product type: Columns, Liquid Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: DPN. Product type: Thin Layer Chromatography, Propoxyphene. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: DPO. Product type: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: DPP. Product type: Free Radical Assay, Methadone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: DPQ. Product type: Liquid Chromatography, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: DPS. Product type: Electrocardiograph. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2340. Implant flag: N. Life-sustain/support flag: N.

Official code: DPT. Product type: Probe, Blood-Flow, Extravascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2120. Implant flag: N. Life-sustain/support flag: N.

Official code: DPW. Product type: Flowmeter, Blood, Cardiovascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2100. Implant flag: N. Life-sustain/support flag: N.

Official code: DPZ. Product type: Oximeter, Ear. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2710. Implant flag: N. Life-sustain/support flag: N.

Official code: DQA. Product type: Oximeter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: DQB. Product type: Phlebograph, Impedance. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2750. Implant flag: N. Life-sustain/support flag: N.

Official code: DQC. Product type: Phonocardiograph. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.2390. Implant flag: N. Life-sustain/support flag: N.

Official code: DQD. Product type: Stethoscope, Electronic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1875. Implant flag: N. Life-sustain/support flag: N.

Official code: DQE. Product type: Catheter, Oximeter, Fiber-Optic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1230. Implant flag: N. Life-sustain/support flag: N.

Official code: DQF. Product type: Actuator, Syringe, Injector Type. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1670. Implant flag: N. Life-sustain/support flag: N.

Official code: DQG. Product type: Microsphere, Trace. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.1360. Call for PMAs 12/26/96 (61 FR 50706 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: DQH. Product type: Cardiograph, Apex (Vibrocardiograph). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2310. Implant flag: N. Life-sustain/support flag: N.

Official code: DQI. Product type: Withdrawal/Infusion Pump. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: DQK. Product type: Computer, Diagnostic, Programmable. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1425. Implant flag: N. Life-sustain/support flag: N.

Official code: DQO. Product type: Catheter, Intravascular, Diagnostic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: DQP. Product type: Kit, Balloon Repair, Catheter. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.1350. Call for PMAs 12/26/96 (61 FR 50706 (9/27/96)) Implant flag: N. Life-sustain/support flag: N.

Official code: DQR. Product type: Cannula, Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: DQT. Product type: Occluder, Catheter Tip. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1370. Implant flag: N. Life-sustain/support flag: N.

Official code: DQX. Product type: Wire, Guide, Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: DQY. Product type: Catheter, Percutaneous. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: DRA. Product type: Catheter, Steerable. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1280. Implant flag: N. Life-sustain/support flag: N.

Official code: DRB. Product type: Stylet, Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1380. Implant flag: N. Life-sustain/support flag: N.

Official code: DRC. Product type: Trocar. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1390. Implant flag: N. Life-sustain/support flag: N.

Official code: DRE. Product type: Dilator, Vessel, For Percutaneous Catheterization. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1310. Implant flag: N. Life-sustain/support flag: N.

Official code: DRF. Product type: Catheter, Electrode Recording, Or Probe, Electrode Recording. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1220. Implant flag: N. Life-sustain/support flag: N.

Official code: DRG. Product type: Transmitters And Receivers, Physiological Signal, Radiofrequency. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2910. Implant flag: N. Life-sustain/support flag: N.

Official code: DRI. Product type: Monitor, Line Isolation. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.2620. Implant flag: N. Life-sustain/support flag: N.

Official code: DRJ. Product type: System, Signal Isolation. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.2600. Implant flag: N. Life-sustain/support flag: N.

Official code: DRK. Product type: Dc-Defibrillator, High Energy, (Including Paddles). Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.5300. PMA to be filed by 12/26/96 (FR 50706 (9/27/96)) Implant flag: N. Life-sustain/support flag: N.

Official code: DRL. Product type: Tester, Defibrillator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5325. Implant flag: N. Life-sustain/support flag: N.

Official code: DRM. Product type: Compressor, Cardiac, External. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: DRN. Product type: Device, Counter-Pulsating, External. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5225. Implant flag: N. Life-sustain/support flag: N.

Official code: DRO. Product type: Pacemaker, Cardiac, External Transcutaneous (Non-Invasive). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5550. Implant flag: N. Life-sustain/support flag: Y.

Official code: DRP. Product type: Tourniquet, Automatic Rotating. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: DRQ. Product type: Amplifier And Signal Conditioner, Transducer Signal. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2060. Implant flag: N. Life-sustain/support flag: N.

Official code: DRR. Product type: Amplifier And Signal Conditioner, Biopotential. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: DRS. Product type: Transducer, Blood-Pressure, Extravascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2850. Implant flag: N. Life-sustain/support flag: N.

Official code: DRT. Product type: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2300. Implant flag: N. Life-sustain/support flag: N.

Official code: DRW. Product type: Adaptor, Lead Switching, Electrocardiograph. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2350. Implant flag: N. Life-sustain/support flag: N.

Official code: DRX. Product type: Electrode, Electrocardiograph. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: DRY. Product type: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4330. Implant flag: N. Life-sustain/support flag: N.

Official code: DRZ. Product type: Oscillometer. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2675. Implant flag: N. Life-sustain/support flag: N.

Official code: DSA. Product type: Cable, Transducer And Electrode, Patient, (Including Connector). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: DSB. Product type: Plethysmograph, Impedance. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. Implant flag: N. Life-sustain/support flag: N.

Official code: DSF. Product type: Recorder, Paper Chart. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.2810. Implant flag: N. Life-sustain/support flag: N.

Official code: DSH. Product type: Recorder, Magnetic Tape, Medical. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: DSI. Product type: Detector And Alarm, Arrhythmia. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1025. Implant flag: N. Life-sustain/support flag: N.

Official code: DSJ. Product type: Alarm, Blood-Pressure. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: DSK. Product type: Computer, Blood-Pressure. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1110. Implant flag: N. Life-sustain/support flag: N.

Official code: DSM. Product type: Alarm, Leakage Current, Portable. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.2640. Implant flag: N. Life-sustain/support flag: N.

Official code: DSP. Product type: System, Balloon, Intra-Aortic And Control. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3535. Implant flag: N. Life-sustain/support flag: N.

Official code: DSQ. Product type: Ventricular (Assist) Bypass. Official classification: Class III. Official category: Unknown. Approved pma: P870072 Implant flag: Y. Life-sustain/support flag: N.

Official code: DSR. Product type: Stimulator, Carotid Sinus Nerve. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3850. Call for PMAs 12/26/96 (61 FR 50706 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: DSS. Product type: Clip, Vascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3250. Implant flag: Y. Life-sustain/support flag: N.

Official code: DST. Product type: Clip, Vena-Cava. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3260. Implant flag: Y. Life-sustain/support flag: N.

Official code: DSW. Product type: Bag, Polymeric Mesh, Pacemaker. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3650. Implant flag: Y. Life-sustain/support flag: N.

Official code: DSY. Product type: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3450. Implant flag: Y. Life-sustain/support flag: N.

Official code: DSZ. Product type: Pacemaker Battery. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3610. Implant flag: Y. Life-sustain/support flag: N.

Official code: DTA. Product type: Tester, Pacemaker Electrode Function. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3720. Implant flag: N. Life-sustain/support flag: N.

Official code: DTB. Product type: Permanent Pacemaker Electrode. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3680. Implant flag: Y. Life-sustain/support flag: N.

Official code: DTC. Product type: Analyzer, Pacemaker Generator Function. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3630. Implant flag: N. Life-sustain/support flag: N.

Official code: DTD. Product type: Pacemaker Lead Adaptor. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: DTE. Product type: Pulse-Generator, Pacemaker, External. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: DTF. Product type: Tools, Pacemaker Service. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3730. Implant flag: N. Life-sustain/support flag: N.

Official code: DTG. Product type: Magnet, Test, Pacemaker. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3690. Implant flag: N. Life-sustain/support flag: N.

Official code: DTH. Product type: Suture, Cardiovascular. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: DTI. Product type: Sizer, Heart-Valve, Prosthesis. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3945. Implant flag: N. Life-sustain/support flag: N.

Official code: DTJ. Product type: Holder, Heart-Valve, Prosthesis. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3935. Implant flag: N. Life-sustain/support flag: N.

Official code: DTK. Product type: Filter, Intravascular, Cardiovascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3375. Implant flag: Y. Life-sustain/support flag: N.

Official code: DTL. Product type: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4290. Implant flag: N. Life-sustain/support flag: N.

Official code: DTM. Product type: Filter, Blood, Cardiopulmonary Bypass, Arterial Line. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4260. Implant flag: N. Life-sustain/support flag: Y.

Official code: DTN. Product type: Reservoir, Blood, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: DTP. Product type: Defoamer, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4230. Implant flag: N. Life-sustain/support flag: Y.

Official code: DTQ. Product type: Console, Heart-Lung Machine, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4220. Implant flag: N. Life-sustain/support flag: Y.

Official code: DTR. Product type: Heat-Exchanger, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4240. Implant flag: N. Life-sustain/support flag: Y.

Official code: DTS. Product type: Sucker, Cardiotomy Return, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: DTW. Product type: Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4340. Implant flag: N. Life-sustain/support flag: N.

Official code: DTX. Product type: Gas Control Unit, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4300. Implant flag: N. Life-sustain/support flag: Y.

Official code: DTY. Product type: Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4410. Implant flag: N. Life-sustain/support flag: N.

Official code: DTZ. Product type: Oxygenator, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4350. Implant flag: N. Life-sustain/support flag: Y.

Official code: DWA. Product type: Control, Pump Speed, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4380. Implant flag: N. Life-sustain/support flag: Y.

Official code: DWB. Product type: Pump, Blood, Cardiopulmonary Bypass, Roller Type. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4370. Implant flag: N. Life-sustain/support flag: Y.

Official code: DWC. Product type: Controller, Temperature, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4250. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: Y.

Official code: DWD. Product type: Suction Control, Intracardiac, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4430. Implant flag: N. Life-sustain/support flag: N.

Official code: DWE. Product type: Tubing, Pump, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4390. Implant flag: N. Life-sustain/support flag: N.

Official code: DWF. Product type: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4210. Implant flag: N. Life-sustain/support flag: N.

Official code: DWG. Product type: Electrosurgical Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: DWH. Product type: Blade, Saw, Surgical, Cardiovascular. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: DWI. Product type: Saw, Electrically Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: DWJ. Product type: System, Thermal Regulating. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5900. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: DWL. Product type: Stocking, Medical Support (To Prevent Pooling Of Blood In Legs). Official classification: Class II. Official category: General Hospital. Regulation number: 880.5780. Implant flag: N. Life-sustain/support flag: N.

Official code: DWM. Product type: Apparatus, Suction, Patient Care. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: DWO. Product type: Needle, Biopsy, Cardiovascular. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: DWP. Product type: Dilator, Vessel, Surgical. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4475. Implant flag: N. Life-sustain/support flag: N.

Official code: DWQ. Product type: Stripper, Vein, External. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4885. Implant flag: N. Life-sustain/support flag: N.

Official code: DWS. Product type: Instruments, Surgical, Cardiovascular. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: DWX. Product type: Stripper, Artery, Intraluminal. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4875. Implant flag: N. Life-sustain/support flag: N.

Official code: DWZ. Product type: Device, Biopsy, Endomyocardial. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4075. Implant flag: N. Life-sustain/support flag: N.

Official code: DXC. Product type: Clamp, Vascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4450. Implant flag: N. Life-sustain/support flag: N.

Official code: DXE. Product type: Catheter, Embolectomy. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: DXF. Product type: Catheter, Septostomy. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5175. Implant flag: N. Life-sustain/support flag: N.

Official code: DXG. Product type: Computer, Diagnostic, Pre-Programmed, Single-Function. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1435. Implant flag: N. Life-sustain/support flag: N.

Official code: DXH. Product type: Transmitters And Receivers, Electrocardiograph, Telephone. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2920. Implant flag: N. Life-sustain/support flag: N.

Official code: DXJ. Product type: Display, Cathode-Ray Tube, Medical. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2450. Implant flag: N. Life-sustain/support flag: N.

Official code: DXK. Product type: Echocardiograph. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2330. Implant flag: N. Life-sustain/support flag: N.

Official code: DXL. Product type: Injector, Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: DXM. Product type: Densitometer. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1450. Implant flag: N. Life-sustain/support flag: N.

Official code: DXN. Product type: System, Measurement, Blood-Pressure, Non-Invasive. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1130. Implant flag: N. Life-sustain/support flag: N.

Official code: DXO. Product type: Transducer, Pressure, Catheter Tip. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2870. Implant flag: N. Life-sustain/support flag: N.

Official code: DXP. Product type: Transducer, Vessel Occlusion. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2890. Implant flag: N. Life-sustain/support flag: N.

Official code: DXQ. Product type: Blood Pressure Cuff. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1120. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure. Implant flag: N. Life-sustain/support flag: N.

Official code: DXR. Product type: Ballistocardiograph. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2320. Implant flag: N. Life-sustain/support flag: N.

Official code: DXS. Product type: Gauge, Pressure, Coronary, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4310. Implant flag: N. Life-sustain/support flag: N.

Official code: DXT. Product type: Injector And Syringe, Angiographic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: DXW. Product type: System, Phonocatheter, Intracavitary. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1270. Implant flag: N. Life-sustain/support flag: N.

Official code: DXX. Product type: System, Catheter Control, Steerable. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1290. Implant flag: N. Life-sustain/support flag: N.

Official code: DXY. Product type: Implantable Pacemaker Pulse-Generator. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3610. Implant flag: Y. Life-sustain/support flag: N.

Official code: DXZ. Product type: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3470. Implant flag: Y. Life-sustain/support flag: N.

Official code: DYB. Product type: Introducer, Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. Implant flag: N. Life-sustain/support flag: N.

Official code: DYC. Product type: Vectorcardiograph. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2400. Implant flag: N. Life-sustain/support flag: N.

Official code: DYE. Product type: Replacement Heart-Valve. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3925. Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87)) Implant flag: Y. Life-sustain/support flag: N.

Official code: DYF. Product type: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3450. Implant flag: Y. Life-sustain/support flag: N.

Official code: DYG. Product type: Catheter, Flow Directed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1240. Implant flag: N. Life-sustain/support flag: N.

Official code: DYH. Product type: Adhesive, Bracket And Tooth Conditioner, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: DYJ. Product type: Retainer, Screw Expansion, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: DYN. Product type: Mouthpiece, Saliva Ejector. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. Implant flag: N. Life-sustain/support flag: N.

Official code: DYO. Product type: Band, Material, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: DYT. Product type: Maintainer, Space Preformed, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5525. Implant flag: N. Life-sustain/support flag: N.

Official code: DYW. Product type: Bracket, Plastic, Orthodontic. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. Implant flag: N. Life-sustain/support flag: N.

Official code: DYX. Product type: Lock, Wire, And Ligature, Intraoral. Official classification: Class II. Official category: Dental. Regulation number: 872.4600. Implant flag: Y. Life-sustain/support flag: N.

Official code: DZA. Product type: Drill, Dental, Intraoral. Official classification: Class I. Official category: Dental. Regulation number: 872.4130. Implant flag: N. Life-sustain/support flag: N.

Official code: DZB. Product type: Headgear, Extraoral, Orthodontic. Official classification: Class II. Official category: Dental. Regulation number: 872.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: DZC. Product type: Wire, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: DZD. Product type: Tube, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: DZE. Product type: Implant, Endosseous, Root-Form. Official classification: Class II. Official category: Dental. Regulation number: 872.3640. Implant flag: Y. Life-sustain/support flag: N.

Official code: DZG. Product type: Suture, Dental. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: DZH. Product type: Saw, Bone, Ac-Powered. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. Implant flag: N. Life-sustain/support flag: N.

Official code: DZI. Product type: Drill, Bone, Powered. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. Implant flag: N. Life-sustain/support flag: N.

Official code: DZJ. Product type: Driver, Wire, And Bone Drill, Manual. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. Implant flag: N. Life-sustain/support flag: N.

Official code: DZK. Product type: Wire, Fixation, Intraosseous. Official classification: Class II. Official category: Dental. Regulation number: 872.4880. Implant flag: Y. Life-sustain/support flag: N.

Official code: DZL. Product type: Screw, Fixation, Intraosseous. Official classification: Class II. Official category: Dental. Regulation number: 872.4880. Implant flag: Y. Life-sustain/support flag: N.

Official code: DZM. Product type: Needle, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: DZN. Product type: Instruments, Dental Hand. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: DZP. Product type: Instrument, Diamond, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4535. Implant flag: N. Life-sustain/support flag: N.

Official code: DZS. Product type: Capsule, Dental, Amalgam. Official classification: Class I. Official category: Dental. Regulation number: 872.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: EAG. Product type: Cephalometer. Official classification: Class II. Official category: Dental. Regulation number: 872.1830. Implant flag: N. Life-sustain/support flag: N.

Official code: EAH. Product type: Cone, Radiographic, Lead-Lined. Official classification: Class I. Official category: Dental. Regulation number: 872.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: EAJ. Product type: Apron, Leaded. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: EAK. Product type: Screen, Leaded, Operator Radiation Protector. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: EAM. Product type: Screen, Intensifying, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1960. Implant flag: N. Life-sustain/support flag: N.

Official code: EAP. Product type: Unit, X-Ray, Intraoral. Official classification: Class II. Official category: Dental. Regulation number: 872.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: EAQ. Product type: Detector, Ultraviolet. Official classification: Class II. Official category: Dental. Regulation number: 872.6350. Implant flag: N. Life-sustain/support flag: N.

Official code: EAS. Product type: Gel, Electrode, For Pulp Tester. Official classification: Class I. Official category: Dental. Regulation number: 872.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: EAT. Product type: Tester, Pulp. Official classification: Class II. Official category: Dental. Regulation number: 872.1720. Implant flag: N. Life-sustain/support flag: N.

Official code: EAX. Product type: Mirror, Mouth. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EAY. Product type: Light, Fiber Optic, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4620. Implant flag: N. Life-sustain/support flag: N.

Official code: EAZ. Product type: Light, Operating, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4630. Implant flag: N. Life-sustain/support flag: N.

Official code: EBA. Product type: Light, Surgical Headlight. Official classification: Class I. Official category: Dental. Regulation number: 872.4630. Implant flag: N. Life-sustain/support flag: N.

Official code: EBC. Product type: Sealant, Pit And Fissure, And Conditioner. Official classification: Class II. Official category: Dental. Regulation number: 872.3765. Implant flag: N. Life-sustain/support flag: N.

Official code: EBD. Product type: Coating, Filling Material, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3310. Implant flag: N. Life-sustain/support flag: N.

Official code: EBE. Product type: Coating, Denture Hydrophilic, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: EBF. Product type: Material, Tooth Shade, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3690. Implant flag: N. Life-sustain/support flag: N.

Official code: EBG. Product type: Crown And Bridge, Temporary, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3770. Implant flag: N. Life-sustain/support flag: N.

Official code: EBH. Product type: Material, Impression Tray, Resin. Official classification: Class I. Official category: Dental. Regulation number: 872.3670. Implant flag: N. Life-sustain/support flag: N.

Official code: EBI. Product type: Resin, Denture, Relining, Repairing, Rebasing. Official classification: Class II. Official category: Dental. Regulation number: 872.3760. Implant flag: N. Life-sustain/support flag: N.

Official code: EBL. Product type: Pin, Retentive And Splinting, And Accessory Instruments. Official classification: Class I. Official category: Dental. Regulation number: 872.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: EBO. Product type: Denture Repair Kit. Official classification: Class II. Official category: Dental. Regulation number: 872.3570. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: EBP. Product type: Reliner, Denture, Over The Counter. Official classification: Class II. Official category: Dental. Regulation number: 872.3560. Implant flag: N. Life-sustain/support flag: N.

Official code: EBR. Product type: Unit, Suction Operatory. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. Implant flag: N. Life-sustain/support flag: N.

Official code: EBW. Product type: Controller, Foot, Handpiece And Cord. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: EBZ. Product type: Activator, Ultraviolet, For Polymerization. Official classification: Class II. Official category: Dental. Regulation number: 872.6070. Implant flag: N. Life-sustain/support flag: N.

Official code: ECB. Product type: Unit, Syringe, Air And/Or Water. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ECC. Product type: Sterilizer, Glass Bead. Official classification: Class III. Official category: Dental. Regulation number: 872.6730. Call for PMAs on 4/21/97 per 62 FR 2902 on 1/27/97 Implant flag: N. Life-sustain/support flag: N.

Official code: ECG. Product type: Sterilizer, Boiling Water. Official classification: Class I. Official category: Dental. Regulation number: 872.6710. Implant flag: N. Life-sustain/support flag: N.

Official code: ECI. Product type: Band, Elastic, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: ECM. Product type: Band, Preformed, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: ECN. Product type: Clamp, Wire, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: ECO. Product type: Spring, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: ECP. Product type: Instrument, Ligature Tucking, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ECQ. Product type: Aligner, Bracket, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ECR. Product type: Setter, Band, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ECS. Product type: Pusher, Band, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ECT. Product type: Driver, Band, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ECX. Product type: Cylinder, Compressed Gas, And Valve. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: EEA. Product type: Plate, Base, Shellac. Official classification: Class I. Official category: Dental. Regulation number: 872.6200. Implant flag: N. Life-sustain/support flag: N.

Official code: EEF. Product type: Clamp, Rubber Dam. Official classification: Class I. Official category: Dental. Regulation number: 872.6300. Implant flag: N. Life-sustain/support flag: N.

Official code: EEG. Product type: Heat Source For Bleaching Teeth. Official classification: Class I. Official category: Dental. Regulation number: 872.6475. Implant flag: N. Life-sustain/support flag: N.

Official code: EEJ. Product type: Guard, Disk. Official classification: Class I. Official category: Dental. Regulation number: 872.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: EFA. Product type: Handpiece, Belt And/Or Gear Driven, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: EFB. Product type: Handpiece, Air-Powered, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: EFC. Product type: Warmer, Anesthetic Tube. Official classification: Class I. Official category: Dental. Regulation number: 872.6100. Implant flag: N. Life-sustain/support flag: N.

Official code: EFD. Product type: Amalgamator, Dental, Ac-Powered. Official classification: Class I. Official category: Dental. Regulation number: 872.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: EFH. Product type: Paper, Articulation. Official classification: Class I. Official category: Dental. Regulation number: 872.6140. Implant flag: N. Life-sustain/support flag: N.

Official code: EFK. Product type: Forceps, Articulation Paper. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EFL. Product type: Forceps, Dressing, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EFN. Product type: Cotton, Roll. Official classification: Class I. Official category: Dental. Regulation number: 872.6050. Implant flag: N. Life-sustain/support flag: N.

Official code: EFQ. Product type: Gauze/Sponge, Internal. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: EFS. Product type: Unit, Oral Irrigation. Official classification: Class I. Official category: Dental. Regulation number: 872.6510. Implant flag: N. Life-sustain/support flag: N.

Official code: EFT. Product type: Cleanser, Denture, Over The Counter. Official classification: Class I. Official category: Dental. Regulation number: 872.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: EFW. Product type: Toothbrush, Manual. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. Implant flag: N. Life-sustain/support flag: N.

Official code: EFX. Product type: Protector, Silicate. Official classification: Class I. Official category: Dental. Regulation number: 872.6670. Implant flag: N. Life-sustain/support flag: N.

Official code: EGD. Product type: Wax, Dental, Intraoral. Official classification: Class I. Official category: Dental. Regulation number: 872.6890. Implant flag: N. Life-sustain/support flag: N.

Official code: EGG. Product type: Attachment, Precision, All. Official classification: Class I. Official category: Dental. Regulation number: 872.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: EGI. Product type: Parallelometer. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EGJ. Product type: Device, Iontophoresis, Other Uses. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5525. Implant flag: N. Life-sustain/support flag: N.

Official code: EGM. Product type: Injector, Jet, Mechanical-Powered. Official classification: Class II. Official category: Dental. Regulation number: 872.4475. Implant flag: N. Life-sustain/support flag: N.

Official code: EGN. Product type: Scissors, Surgical Tissue, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EGQ. Product type: Injector, Jet, Gas-Powered. Official classification: Class II. Official category: Dental. Regulation number: 872.4465. Implant flag: N. Life-sustain/support flag: N.

Official code: EGS. Product type: Handpiece, Contra- And Right-Angle Attachment, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: EGT. Product type: Controller, Temperature, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: EGW. Product type: Dryer, Film, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: EGY. Product type: Processor, Radiographic-Film, Automatic, Dental. Official classification: Class II. Official category: Radiology. Regulation number: 892.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: EGZ. Product type: Holder, Film, X-Ray. Official classification: Class I. Official category: Dental. Regulation number: 872.1905. Implant flag: N. Life-sustain/support flag: N.

Official code: EHA. Product type: Aligner, Beam, X-Ray. Official classification: Class I. Official category: Dental. Regulation number: 872.1820. Implant flag: N. Life-sustain/support flag: N.

Official code: EHB. Product type: Collimator, X-Ray. Official classification: Class I. Official category: Dental. Regulation number: 872.1840. Implant flag: N. Life-sustain/support flag: N.

Official code: EHD. Product type: Unit, X-Ray, Extraoral With Timer. Official classification: Class II. Official category: Dental. Regulation number: 872.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: EHE. Product type: Dispenser, Mercury And/Or Alloy. Official classification: Class I. Official category: Dental. Regulation number: 872.3080. Implant flag: N. Life-sustain/support flag: N.

Official code: EHJ. Product type: Disk, Abrasive. Official classification: Class I. Official category: Dental. Regulation number: 872.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: EHK. Product type: Cup, Prophylaxis. Official classification: Class I. Official category: Dental. Regulation number: 872.6290. Implant flag: N. Life-sustain/support flag: N.

Official code: EHL. Product type: Point, Abrasive. Official classification: Class I. Official category: Dental. Regulation number: 872.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: EHM. Product type: Strip, Polishing Agent. Official classification: Class I. Official category: Dental. Regulation number: 872.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: EHO. Product type: Bar, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: EHP. Product type: Clasp, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.3285. Implant flag: N. Life-sustain/support flag: N.

Official code: EHQ. Product type: Cusp, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.3360. Implant flag: N. Life-sustain/support flag: N.

Official code: EHR. Product type: Pad, Denture, Over The Counter. Official classification: Class II. Official category: Dental. Regulation number: 872.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: EHS. Product type: Cushion, Denture, Over The Counter. Official classification: Class II. Official category: Dental. Regulation number: 872.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: EHY. Product type: Tray, Impression, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.6880. Implant flag: N. Life-sustain/support flag: N.

Official code: EHZ. Product type: Evacuator, Oral Cavity. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. Implant flag: N. Life-sustain/support flag: N.

Official code: EIA. Product type: Unit, Operative Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. Implant flag: N. Life-sustain/support flag: N.

Official code: EIB. Product type: Syringe, Irrigating (Dental). Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIC. Product type: Syringe, Periodontic, Endodontic, Irrigating. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EID. Product type: Syringe, Restorative And Impression Material. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIE. Product type: Dam, Rubber. Official classification: Class I. Official category: Dental. Regulation number: 872.6300. Implant flag: N. Life-sustain/support flag: N.

Official code: EIF. Product type: Accessories, Retractor, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIG. Product type: Retractor, All Types. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIH. Product type: Powder, Porcelain. Official classification: Class II. Official category: Dental. Regulation number: 872.6660. Implant flag: N. Life-sustain/support flag: N.

Official code: EIK. Product type: Carver, Wax, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIL. Product type: Gauge, Depth, Instrument, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIR. Product type: Scissors, Collar And Crown. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIS. Product type: Remover, Crown. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIT. Product type: Applicator, Rapid Wax, Dental. Official classification: Class II. Official category: Dental. Regulation number: 872.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: EIX. Product type: Probe, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EIY. Product type: Instrument, Filling, Plastic, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EJB. Product type: Handle, Instrument, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EJE. Product type: Frame, Rubber Dam. Official classification: Class I. Official category: Dental. Regulation number: 872.6300. Implant flag: N. Life-sustain/support flag: N.

Official code: EJF. Product type: Bracket, Metal, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: EJG. Product type: Forceps, Rubber Dam Clamp. Official classification: Class I. Official category: Dental. Regulation number: 872.6300. Implant flag: N. Life-sustain/support flag: N.

Official code: EJH. Product type: Alloy, Metal, Base. Official classification: Class II. Official category: Dental. Regulation number: 872.3710. Implant flag: N. Life-sustain/support flag: N.

Official code: EJI. Product type: Syringe, Cartridge. Official classification: Class II. Official category: Dental. Regulation number: 872.6770. Implant flag: N. Life-sustain/support flag: N.

Official code: EJJ. Product type: Alloy, Amalgam. Official classification: Class II. Official category: Dental. Regulation number: 872.3070. Implant flag: N. Life-sustain/support flag: N.

Official code: EJK. Product type: Liner, Cavity, Calcium Hydroxide. Official classification: Class II. Official category: Dental. Regulation number: 872.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: EJL. Product type: Bur, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: EJP. Product type: Articulators. Official classification: Class I. Official category: Dental. Regulation number: 872.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: EJQ. Product type: Wheel, Polishing Agent. Official classification: Class I. Official category: Dental. Regulation number: 872.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: EJR. Product type: Agent, Polishing, Abrasive, Oral Cavity. Official classification: Class I. Official category: Dental. Regulation number: 872.6030. Implant flag: N. Life-sustain/support flag: N.

Official code: EJS. Product type: Alloy, Other Noble Metal. Official classification: Class II. Official category: Dental. Regulation number: 872.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: EJT. Product type: Alloy, Gold-Based Noble Metal. Official classification: Class II. Official category: Dental. Regulation number: 872.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: EJW. Product type: Clasp, Wire. Official classification: Class I. Official category: Dental. Regulation number: 872.3285. Implant flag: N. Life-sustain/support flag: N.

Official code: EJX. Product type: Anchor, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.3130. Implant flag: N. Life-sustain/support flag: N.

Official code: EJY. Product type: Pliers, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EJZ. Product type: Knife, Margin Finishing, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKA. Product type: File, Margin Finishing, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKB. Product type: Explorer, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKC. Product type: Excavator, Dental, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKD. Product type: Instrument, Cutting, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKE. Product type: Curette, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKF. Product type: Instrument, Contouring, Matrix, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKG. Product type: Condenser, Amalgam And Foil, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKH. Product type: Carver, Dental Amalgam, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKI. Product type: Carrier, Amalgam, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKJ. Product type: Burnisher, Operative. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKK. Product type: Spreader, Pulp Canal Filling Material, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKL. Product type: Point, Silver, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.3840. Implant flag: N. Life-sustain/support flag: N.

Official code: EKM. Product type: Gutta-Percha. Official classification: Class I. Official category: Dental. Regulation number: 872.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: EKN. Product type: Point, Paper, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: EKO. Product type: Denture Preformed (Partially Prefabricated Denture). Official classification: Class II. Official category: Dental. Regulation number: 872.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: EKP. Product type: Reamer, Pulp Canal, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKQ. Product type: Preparer, Root Canal Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKR. Product type: Plugger, Root Canal, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKS. Product type: File, Pulp Canal, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKT. Product type: Curette, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKW. Product type: Broach, Endodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EKX. Product type: Handpiece, Direct Drive, Ac-Powered. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: EKY. Product type: Handpiece, Water-Powered. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: EKZ. Product type: Unit, Electrosurgical, And Accessories, Dental. Official classification: Class II. Official category: Dental. Regulation number: 872.4920. Implant flag: N. Life-sustain/support flag: N.

Official code: ELA. Product type: Instrument, Hand, Calculus Removal. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: ELB. Product type: Scaler, Rotary. Official classification: Class II. Official category: Dental. Regulation number: 872.4840. Implant flag: N. Life-sustain/support flag: N.

Official code: ELC. Product type: Scaler, Ultrasonic. Official classification: Class II. Official category: Dental. Regulation number: 872.4850. Implant flag: N. Life-sustain/support flag: N.

Official code: ELE. Product type: Implant, Subperiosteal. Official classification: Class II. Official category: Dental. Regulation number: 872.3645. Implant flag: Y. Life-sustain/support flag: N.

Official code: ELJ. Product type: Teeth, Artificial, Posterior With Metal Insert. Official classification: Class I. Official category: Dental. Regulation number: 872.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: ELK. Product type: Teeth, Artificial, Backing And Facing. Official classification: Class I. Official category: Dental. Regulation number: 872.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: ELL. Product type: Teeth, Porcelain. Official classification: Class II. Official category: Dental. Regulation number: 872.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: ELM. Product type: Denture, Plastic, Teeth. Official classification: Class II. Official category: Dental. Regulation number: 872.3590. Implant flag: N. Life-sustain/support flag: N.

Official code: ELN. Product type: Teeth, Preformed Gold Denture. Official classification: Class I. Official category: Dental. Regulation number: 872.3580. Implant flag: N. Life-sustain/support flag: N.

Official code: ELO. Product type: Cusp, Gold And Stainless Steel. Official classification: Class I. Official category: Dental. Regulation number: 872.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: ELR. Product type: Post, Root Canal. Official classification: Class I. Official category: Dental. Regulation number: 872.3810. Implant flag: N. Life-sustain/support flag: N.

Official code: ELS. Product type: Splint, Endodontic Stabilizing. Official classification: Class II. Official category: Dental. Regulation number: 872.3890. Implant flag: N. Life-sustain/support flag: N.

Official code: ELW. Product type: Material, Impression. Official classification: Class II. Official category: Dental. Regulation number: 872.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: ELY. Product type: Mercury. Official classification: Class II. Official category: Dental. Regulation number: 872.3070. Implant flag: N. Life-sustain/support flag: N.

Official code: ELZ. Product type: Crown, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: EMA. Product type: Cement, Dental. Official classification: Class II. Official category: Dental. Regulation number: 872.3275. Implant flag: N. Life-sustain/support flag: N.

Official code: EMB. Product type: Zinc Oxide Eugenol. Official classification: Class I. Official category: Dental. Regulation number: 872.3275. Implant flag: N. Life-sustain/support flag: N.

Official code: EMD. Product type: Hemostat, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EME. Product type: Punch, Biopsy, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMF. Product type: Knife, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: EMG. Product type: Forceps, Tooth Extractor, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMH. Product type: Forceps, Rongeur, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMI. Product type: File, Bone, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMJ. Product type: Elevator, Surgical, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMK. Product type: Curette, Surgical, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EML. Product type: Chisel, Bone, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMM. Product type: Chisel, Osteotome, Surgical. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMN. Product type: Scaler, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMO. Product type: Knife, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMP. Product type: Marker, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMQ. Product type: Hoe, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMR. Product type: File, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMS. Product type: Curette, Periodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: EMX. Product type: Balloon, Epistaxis. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: ENW. Product type: Catheter, Nasopharyngeal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4175. Implant flag: N. Life-sustain/support flag: N.

Official code: ENZ. Product type: Telescope, Laryngeal-Bronchial. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: EOB. Product type: Nasopharyngoscope (Flexible Or Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4760. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: EOQ. Product type: Bronchoscope (Flexible Or Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: EOX. Product type: Esophagoscope (Flexible Or Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4710. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: EPE. Product type: Brush, Cleaning, Tracheal Tube. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5795. Implant flag: N. Life-sustain/support flag: N.

Official code: EPF. Product type: Hearing Aid, Group And Auditory Trainer. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: EPG. Product type: Stimulator, Transdermal. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: EPN. Product type: Pump, Nebulizer, Manual. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: EPP. Product type: Splint, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: EPT. Product type: Microscope, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4700. Implant flag: N. Life-sustain/support flag: N.

Official code: EPW. Product type: Support, Head, Surgical, Ent. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: EPY. Product type: Speculum, Ent. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: EQH. Product type: Source, Carrier, Fiberoptic Light. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: EQJ. Product type: Bur, Ear, Nose And Throat. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4140. Implant flag: N. Life-sustain/support flag: N.

Official code: EQL. Product type: Laryngostroboscope. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4750. Implant flag: N. Life-sustain/support flag: N.

Official code: EQN. Product type: Laryngoscope, Nasopharyngoscope. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4760. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: ERA. Product type: Otoscope. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4770. Implant flag: N. Life-sustain/support flag: N.

Official code: ERL. Product type: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4250. Implant flag: N. Life-sustain/support flag: N.

Official code: ERY. Product type: Drape, Surgical, Ent. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: ESD. Product type: Hearing Aid, Air-Conduction, Prescription. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3300. An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid. Implant flag: N. Life-sustain/support flag: N.

Official code: ESE. Product type: Larynx, Artificial (Battery-Powered). Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3375. Implant flag: N. Life-sustain/support flag: N.

Official code: ESF. Product type: Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3500. Implant flag: Y. Life-sustain/support flag: N.

Official code: ESH. Product type: Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: ESI. Product type: Polymer, Natural-Absorbable Gelatin Material. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: ESW. Product type: Prosthesis, Esophageal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3610. Implant flag: Y. Life-sustain/support flag: N.

Official code: ESX. Product type: Tack, Sacculotomy (Cody Tack). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3760. Implant flag: Y. Life-sustain/support flag: N.

Official code: ESZ. Product type: Tube, Shunt, Endolymphatic. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3820. Implant flag: Y. Life-sustain/support flag: N.

Official code: ETA. Product type: Replacement, Ossicular Prosthesis, Total. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3495. Implant flag: Y. Life-sustain/support flag: N.

Official code: ETB. Product type: Prosthesis, Partial Ossicular Replacement. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3450. Implant flag: Y. Life-sustain/support flag: N.

Official code: ETC. Product type: Mold, Middle-Ear. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3430. Implant flag: Y. Life-sustain/support flag: N.

Official code: ETD. Product type: Tube, Tympanostomy. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3880. Implant flag: Y. Life-sustain/support flag: N.

Official code: ETF. Product type: Unit, Examining/Treatment, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: ETK. Product type: Tube, Toynbee Diagnostic. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1925. Implant flag: N. Life-sustain/support flag: N.

Official code: ETM. Product type: Gustometer, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: ETN. Product type: Stimulator, Nerve. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1820. Implant flag: N. Life-sustain/support flag: N.

Official code: ETP. Product type: Stimulator, Caloric-Water. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: ETR. Product type: Adaptor, Short Increment Sensitivity Index (Sisi). Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: ETS. Product type: Generator, Electronic Noise (For Audiometric Testing). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1120. Implant flag: N. Life-sustain/support flag: N.

Official code: ETT. Product type: Cushion, Earphone (For Audiometric Testing). Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: ETW. Product type: Calibrator, Hearing Aid / Earphone And Analysis Systems. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3310. Implant flag: N. Life-sustain/support flag: N.

Official code: ETY. Product type: Tester, Auditory Impedance. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1090. Implant flag: N. Life-sustain/support flag: N.

Official code: EWA. Product type: Set, Audiometer Calibration. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1080. Implant flag: N. Life-sustain/support flag: N.

Official code: EWC. Product type: Chamber, Acoustic (For Audiometric Testing). Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1060. Implant flag: N. Life-sustain/support flag: N.

Official code: EWD. Product type: Protector, Hearing (Insert). Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: EWE. Product type: Protector, Hearing (Circumaural). Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: EWG. Product type: Laser, Ent Microsurgical Carbon-Dioxide. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: EWL. Product type: Prosthesis, Laryngeal (Taub). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3730. Implant flag: N. Life-sustain/support flag: N.

Official code: EWO. Product type: Audiometer. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: EWQ. Product type: Saw, Surgical, Ent (Electric Or Pneumatic). Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: EWT. Product type: Device, Antichoke, Suction. Official classification: Class III. Official category: Ear, Nose, Throat. Regulation number: 874.5350. Call for PMAs on 7/13/99 per 64 FR 18329 on 4/14/99 Implant flag: N. Life-sustain/support flag: N.

Official code: EWW. Product type: Device, Antichoke, Tongs. Official classification: Class III. Official category: Ear, Nose, Throat. Regulation number: 874.5370. Implant flag: N. Life-sustain/support flag: N.

Official code: EWY. Product type: Mediastinoscope, Surgical. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4720. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: EXA. Product type: Selector, Size, Ostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EXB. Product type: Collector, Ostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EXD. Product type: Irrigator, Ostomy. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5895. Implant flag: N. Life-sustain/support flag: N.

Official code: EXE. Product type: Protector, Ostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EXF. Product type: Bag, Bile Collecting. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5010. Implant flag: N. Life-sustain/support flag: N.

Official code: EXG. Product type: Bag, Urine Collecting, Ureterostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EXH. Product type: Bag, Urinary, Ileostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EXI. Product type: Device, Paste-On For Incontinence, Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: EXJ. Product type: Device, Incontinence, Urosheath Type, Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: EXM. Product type: Truss, Umbilical. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5970. Implant flag: N. Life-sustain/support flag: N.

Official code: EXN. Product type: Support, Hernia. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5970. Implant flag: N. Life-sustain/support flag: N.

Official code: EXQ. Product type: Cystometer, Electrical Recording. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: EXR. Product type: Urinometer, Mechanical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: EXS. Product type: Urinometer, Electrical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: EXW. Product type: Pill, Radio. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1725. Implant flag: N. Life-sustain/support flag: N.

Official code: EXX. Product type: Probe, Rectal, Non-Powered. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: EXY. Product type: Uroflowmeter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: EXZ. Product type: Equipment, Photographic, For Physiologic Function Monitor. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: EYA. Product type: Stylet, Ureteral. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EYB. Product type: Catheter, Ureteral, Gastro-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EYC. Product type: Catheter, Upper Urinary Tract. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EYD. Product type: Stirrups. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4890. Implant flag: N. Life-sustain/support flag: N.

Official code: EYF. Product type: Protector, Wound, Plastic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. Implant flag: N. Life-sustain/support flag: N.

Official code: EYH. Product type: Table, Cysto, Non-Electrical. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4890. Implant flag: N. Life-sustain/support flag: N.

Official code: EYI. Product type: Adaptor, Ureteral Catheter. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EYJ. Product type: Holder, Ureteral Catheter. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EYK. Product type: Connector, Ureteral Catheter. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EYN. Product type: Tray, Irrigation, Sterile. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: EYQ. Product type: Garment, Protective, For Incontinence. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5920. Implant flag: N. Life-sustain/support flag: N.

Official code: EYR. Product type: Tourniquet, Gastro-Urology. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EYS. Product type: Ribdam. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4560. Implant flag: N. Life-sustain/support flag: N.

Official code: EYT. Product type: Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: EYX. Product type: Drape, Pure Latex Sheet, With Self-Retaining Finger Cot. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: EYY. Product type: Drape, Urological, Disposable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: EYZ. Product type: System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: EZB. Product type: Stylet For Catheter, Gastro-Urology. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EZC. Product type: Catheter, Coude. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EZD. Product type: Catheter, Straight. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EZK. Product type: Catheter, Retention Type. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: EZL. Product type: Catheter, Retention Type, Balloon. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: EZM. Product type: Dilator, Esophageal (Metal Olive) Gastro-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5365. Implant flag: N. Life-sustain/support flag: N.

Official code: EZN. Product type: Dilator, Catheter, Ureteral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5470. Implant flag: N. Life-sustain/support flag: N.

Official code: EZO. Product type: Urethrotome. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4770. Implant flag: N. Life-sustain/support flag: N.

Official code: EZP. Product type: Rod, Colostomy. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4270. Implant flag: N. Life-sustain/support flag: N.

Official code: EZQ. Product type: Pouch, Colostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EZR. Product type: Cement, Stomal Appliance, Ostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EZS. Product type: Appliance, Colostomy, Disposable. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: EZT. Product type: Pacemaker, Bladder. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.5270. Call for PMAs 12/26/96 (61 FR 50707 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: EZW. Product type: Stimulator, Electrical, Implantable, For Incontinence. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.5270. PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: EZX. Product type: Mesh, Surgical, Metal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: EZY. Product type: Device, Incontinence, Mechanical/Hydraulic. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.5280. PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00)) Implant flag: Y. Life-sustain/support flag: N.

Official code: EZZ. Product type: Prosthesis, Vas Deferens. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAA. Product type: Replacer, Urethral. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAB. Product type: Replacer, Ureteral. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAC. Product type: Valve, Ureterovesicle. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAD. Product type: Stent, Ureteral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4620. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAE. Product type: Prosthesis, Penile. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.3630. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAF. Product type: Prosthesis, Testicular. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.3750. Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95 Implant flag: Y. Life-sustain/support flag: N.

Official code: FAG. Product type: Prosthesis, Urethral Sphincter. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: FAH. Product type: Dilator, Urethral, Mechanical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: FAJ. Product type: Cystoscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FAK. Product type: Panendoscope (Gastroduodenoscope). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FAL. Product type: Panendoscope (Urethroscope). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FAM. Product type: Sigmoidoscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. to examine and perform procedures within the sigmoid (descending) colon Implant flag: N. Life-sustain/support flag: N.

Official code: FAN. Product type: Sigmoidoscope, Rigid, Electrical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FAO. Product type: Device, Cystometric, Air. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: FAP. Product type: Cystometric Gas (Carbon-Dioxide) On Hydraulic Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: FAQ. Product type: Bag, Urine Collection, Leg, For External Use, Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: FAR. Product type: Unit, Electrosurgical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FAS. Product type: Electrode, Electrosurgical, Active, Urological. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FAT. Product type: Bougie, Esophageal, And Gastrointestinal, Gastro-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5365. Implant flag: N. Life-sustain/support flag: N.

Official code: FAX. Product type: Bougie, Urological. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: FAZ. Product type: System, Cryosurgical, Liquid Nitrogen, For Urology. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: FBI. Product type: Rongeur, Cystoscopic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FBJ. Product type: Cord, Electric For Transurethral Surgical Instrument. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FBK. Product type: Endoscopic Injection Needle, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: FBM. Product type: Cannula And Trocar, Suprapubic, Non-Disposable. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: FBN. Product type: Choledochoscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FBO. Product type: Cystourethroscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FBP. Product type: Telescope, Rigid, Endoscopic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FBQ. Product type: Trocar, Gastro-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: FBR. Product type: Urethrometer. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: FBS. Product type: Sound, Metal, Interconnected. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4590. Implant flag: N. Life-sustain/support flag: N.

Official code: FBW. Product type: Filiform And Filiform Follower. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: FBX. Product type: Sound, Urethral, Metal Or Plastic. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: FBY. Product type: Cooler, Esophageal And Gastric. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: FBZ. Product type: Cooler, Prostatic. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: FCB. Product type: Bag, Hemostatic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FCC. Product type: Endoscopic Magnetic Retriever. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. to endoscopically retrieve magnetic foreign objects Implant flag: N. Life-sustain/support flag: N.

Official code: FCD. Product type: Barium Enema Kit. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5210. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: FCE. Product type: Enema Kit. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5210. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: FCF. Product type: Instrument, Biopsy, Mechanical, Gastrointestinal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: FCG. Product type: Biopsy Needle. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: FCH. Product type: Tray, Biopsy, Without Biopsy Instruments. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FCI. Product type: Punch, Biopsy. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: FCK. Product type: Instrument, Biopsy, Suction. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: FCL. Product type: Forceps, Biopsy, Non-Electric. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: FCM. Product type: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: FCN. Product type: Urinary Drainage Collection Kit, For Indwelling Catheter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: FCO. Product type: Box, Battery, Rechargeable. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FCP. Product type: Box, Battery, Pocket. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FCQ. Product type: Light Source, Incandescent, Diagnostic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FCR. Product type: Light Source, Photographic, Fiberoptic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FCS. Product type: Light, Catheter, Fiberoptic, Glass, Ureteral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4020. Implant flag: N. Life-sustain/support flag: N.

Official code: FCT. Product type: Headlight, Fiberoptic Focusing. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4335. Implant flag: N. Life-sustain/support flag: N.

Official code: FCW. Product type: Light Source, Fiberoptic, Routine. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FCX. Product type: Insufflator, Automatic Carbon-Dioxide For Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FCY. Product type: Bulb, Inflation, For Endoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles. Implant flag: N. Life-sustain/support flag: N.

Official code: FCZ. Product type: Tube, Smoke Removal, Endoscopic. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FDA. Product type: Enteroscope And Accessories. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FDB. Product type: Plate, Patient. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FDC. Product type: Resectoscope, Working Element. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FDE. Product type: Laparoscopy Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: FDF. Product type: Colonoscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FDG. Product type: Retractor, Fiberoptic. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: FDI. Product type: Snare, Flexible. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FDJ. Product type: Snare, Rigid Self-Opening. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FDL. Product type: Wristlet, Patient Return. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FDP. Product type: Apparatus, Pneumoperitoneum, Automatic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FDR. Product type: Sphyncteroscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FDS. Product type: Gastroscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FDT. Product type: Duodenoscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FDW. Product type: Esophagoscope, Rigid, Gastro-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FDX. Product type: Endoscopic Cytology Brush. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To collect cells for cytological evaluation. Implant flag: N. Life-sustain/support flag: N.

Official code: FDY. Product type: Device, Measuring, For Panendoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FDZ. Product type: Attachment, Eyepiece, For Insertion Of Prescription Lens. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FEA. Product type: Attachment, Teaching, For Endoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FEB. Product type: Accessories, Cleaning, For Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FEC. Product type: Obturator, For Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FED. Product type: Endoscopic Access Overtube, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation. Implant flag: N. Life-sustain/support flag: N.

Official code: FEF. Product type: Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FEG. Product type: Tube, Double Lumen For Intestinal Decompression And/Or Intubation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FEH. Product type: Electrode, Flexible Suction Coagulator. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FEI. Product type: Instrument, Special Lens, For Endoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FEJ. Product type: Attachment, Binocular, For Endoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FEM. Product type: Accessories, Photographic, For Endoscope (Exclude Light Sources). Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FEN. Product type: Device, Cystometric, Hydraulic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: FEO. Product type: Lithotriptor, Ultrasonic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4480. Implant flag: N. Life-sustain/support flag: N.

Official code: FEQ. Product type: Pump, Air, Non-Manual, For Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FER. Product type: Anoscope And Accessories. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To examine and perform procedures within the anus and rectum. Implant flag: N. Life-sustain/support flag: N.

Official code: FES. Product type: Recorder, External, Pressure, Amplifier & Transducer. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1725. Implant flag: N. Life-sustain/support flag: N.

Official code: FET. Product type: Endoscopic Video Imaging System/Component, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To allow for visualization of body cavities through an endoscope by projecting images to a monitor. Implant flag: N. Life-sustain/support flag: N.

Official code: FEW. Product type: Catheter, Malecot. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: FEX. Product type: Instrument, Catheter, Punch. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: FEZ. Product type: Catheter And Tube, Suprapubic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: Y. Life-sustain/support flag: N.

Official code: FFA. Product type: Tube, Drainage, Suprapubic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: FFD. Product type: Evacuator, Bladder, Manually Operated. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: FFE. Product type: System, Water Jet Catheter, Renal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4650. Implant flag: N. Life-sustain/support flag: N.

Official code: FFF. Product type: Cover, Biopsy Forceps. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: FFG. Product type: Device, Urine Flow Rate Measuring, Non-Electrical, Disposable. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: FFH. Product type: Collector, Urine, Pediatric, For Indwelling Catheter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: FFI. Product type: System, Alarm, Electrosurgical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FFK. Product type: Lithotriptor, Electro-Hydraulic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4480. Implant flag: N. Life-sustain/support flag: N.

Official code: FFL. Product type: Dislodger, Stone, Basket, Ureteral, Metal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4680. Implant flag: N. Life-sustain/support flag: N.

Official code: FFN. Product type: Clamp, Non-Electrical. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FFO. Product type: Retractor, Self-Retaining. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FFP. Product type: Dilator, Rectal. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5450. Implant flag: N. Life-sustain/support flag: N.

Official code: FFQ. Product type: Speculum, Rectal. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FFR. Product type: Device, Locking, For Intestinal Clamp. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FFS. Product type: Image, Illumination, Fiberoptic, For Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FFT. Product type: Electrode, Ph, Stomach. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1400. Implant flag: N. Life-sustain/support flag: N.

Official code: FFW. Product type: String And Tubes, Gastrointestinal, To Locate Internal Bleeding. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FFX. Product type: System, Gastrointestinal Motility (Electrical). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1725. Implant flag: N. Life-sustain/support flag: N.

Official code: FFY. Product type: Adaptor, Bulbs, Miscellaneous, For Endoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FFZ. Product type: Cord, Electric, For Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FGA. Product type: Kit, Nephroscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FGB. Product type: Ureteroscope And Accessories, Flexible/Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: FGC. Product type: Urethroscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FGD. Product type: Catheter, Retention, Barium Enema With Bag. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FGE. Product type: Stents, Drains And Dilators For The Biliary Ducts. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5010. Implant flag: Y. Life-sustain/support flag: Y.

Official code: FGF. Product type: Catheter, Ureteral Disposable (X-Ray). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: FGH. Product type: Catheter, Double Lumen Female Urethrographic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: FGI. Product type: Catheter, Urethrographic, Male. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: FGK. Product type: Tripsor, Stone, Bladder. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: FGM. Product type: Probe And Director, Gastro-Urology. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FGN. Product type: Retractor, Non-Self-Retaining. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FGO. Product type: Dislodger, Stone, Flexible. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4680. Implant flag: N. Life-sustain/support flag: N.

Official code: FGS. Product type: Carrier, Sponge, Endoscopic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FGW. Product type: Clamp, Electrical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FGX. Product type: Snare, Non-Electrical. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FGY. Product type: Cannula, Injection. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: FHA. Product type: Clamp, Penile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: FHB. Product type: Hook, Gastro-Urology. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FHC. Product type: Adaptor To The Cord, For Transurethral Surgical Instrument. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FHF. Product type: System, Evacuator, Fluid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: FHG. Product type: Bell, Circumcision. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: FHH. Product type: Crusher, Spur, Colostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FHI. Product type: Ring, Laparotomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FHJ. Product type: Shield, Circumcision. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: FHK. Product type: Spreader, Bladder Neck. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FHL. Product type: Scoop. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FHM. Product type: Apparatus, Suturing, Stomach And Intestinal. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FHN. Product type: Ligator, Hemorrhoidal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: FHO. Product type: Pneumoperitoneum Needle. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. For establishment of a pneumoperitoneum in abdomen. Implant flag: N. Life-sustain/support flag: N.

Official code: FHP. Product type: Needle, Pneumoperitoneum, Simple. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FHQ. Product type: Holder, Needle, Gastroenterologic. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FHR. Product type: Needle, Gastro-Urology. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FHS. Product type: Dialyzer, Single Coil. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FHT. Product type: Set, Gavage, Infant, Sterile. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FHW. Product type: Device, Impotence, Mechanical/Hydraulic. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.3350. PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00)) Implant flag: Y. Life-sustain/support flag: N.

Official code: FHX. Product type: Jelly, Lubricating, For Transurethral Surgical Instrument. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FHY. Product type: Jelly, Contact, For Transurethral Surgical Instrument. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FHZ. Product type: Desiccator, Transurethral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: FIA. Product type: Chair, Dialysis, Unpowered, Without Scales. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FIB. Product type: Protector, Transducer, Dialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FID. Product type: Tubing, Dialysate. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIE. Product type: Needle, Fistula. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FIF. Product type: Set, Dialysis, Single Needle With Uni-Directional Pump. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIG. Product type: Clamp, Tubing, Blood, Automatic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIH. Product type: Pump, Infusion Or Syringe, Extra-Luminal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FII. Product type: System, Dialysate Delivery, Sealed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5860. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIJ. Product type: System, Dialysate Delivery, Recirculating, Single Pass. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIK. Product type: System, Dialysate Delivery, Recirculating. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIL. Product type: System, Dialysate Delivery, Single Pass. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIN. Product type: Tank, Holding, Dialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FIP. Product type: Subsystem, Water Purification. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5665. Implant flag: N. Life-sustain/support flag: N.

Official code: FIQ. Product type: Cannula, A-V Shunt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: FIR. Product type: Pump, Blood, Extra-Luminal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIS. Product type: Flowmeter, Dialysate. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIW. Product type: Alarm, Pillow Pressure. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FIZ. Product type: Meter, Conductivity, Non-Remote. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJA. Product type: Manometer, Water. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FJB. Product type: Detector, Dialysate Level. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJC. Product type: Detector, Blood Level. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJD. Product type: Detector, Leak, Blood. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJF. Product type: Detector, Air Bubble. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJG. Product type: Dialyzer, Parallel Flow. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJH. Product type: Dialyzer, Disposable. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5830. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJI. Product type: Dialyzer, Capillary, Hollow Fiber. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJJ. Product type: Dialyzer, Twin Coil. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJK. Product type: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJL. Product type: Resectoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FJM. Product type: Guard, Shunt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJN. Product type: Stabilizer, Shunt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJO. Product type: Plier, Tube. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJP. Product type: Adaptor, Y. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FJQ. Product type: Connector, Shunt. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJR. Product type: Forceps, Disconnect. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJS. Product type: Catheter, Peritoneal, Long-Term Indwelling. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: Y. Life-sustain/support flag: N.

Official code: FJT. Product type: Intracatheter, Dialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FJW. Product type: Ring, Joint. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJX. Product type: Ring, Crimp. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJY. Product type: Plier, Crimp. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FJZ. Product type: Declotting Tray, Kit (Including Contents). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKA. Product type: Dilator, Vessel. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: FKB. Product type: Connector, Blood Tubing, Infusion T. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKC. Product type: Clamp, Cannula. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: FKD. Product type: Canister, Coil. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKE. Product type: Tie, Dialysis. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKF. Product type: Gun, Tie, Dialysis. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKG. Product type: Tray, Start/Stop (Including Contents), Dialysis. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKH. Product type: Solution-Test Standard-Conductivity, Dialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKI. Product type: Set, Dialyzer Holder. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKJ. Product type: Filter, Blood, Dialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKK. Product type: Clamp, Line. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: FKL. Product type: Insert, Pump, Blood. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKM. Product type: Adaptor, Fistula. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FKN. Product type: Adaptor, Shunt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: FKO. Product type: Catheter, Peritoneal Dialysis, Single Use. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKP. Product type: System, Dialysate Delivery, Single Patient. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKQ. Product type: System, Dialysate Delivery, Central Multiple Patient. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKR. Product type: Subsystem, Proportioning. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKT. Product type: System, Dialysate Delivery, Sorbent Regenerated. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5600. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKW. Product type: Tip, Vessel. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: FKX. Product type: System, Peritoneal, Automatic Delivery. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: N. Life-sustain/support flag: Y.

Official code: FKY. Product type: Connector, Tubing, Dialysate. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FLA. Product type: Monitor, Temperature, Dialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FLB. Product type: Meter, Conductivity, Induction, Remote Type. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FLC. Product type: Station, Dialysis Control, Negative Pressure Type. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: FLD. Product type: Apparatus, Hemoperfusion, Sorbent. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: FLE. Product type: Sterilizer, Steam. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6880. Implant flag: N. Life-sustain/support flag: N.

Official code: FLF. Product type: Sterilizer, Ethylene-Oxide Gas. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6860. Implant flag: N. Life-sustain/support flag: N.

Official code: FLG. Product type: Cleaner, Ultrasonic, Medical Instrument. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6150. Implant flag: N. Life-sustain/support flag: N.

Official code: FLH. Product type: Washer Of Body Waste Receptacles. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6800. Implant flag: N. Life-sustain/support flag: N.

Official code: FLI. Product type: Cabinet, Ethylene-Oxide Gas Aerator. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6100. Implant flag: N. Life-sustain/support flag: N.

Official code: FLJ. Product type: Unit, Airflow, Laminar. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: FLK. Product type: Thermometer, Clinical Mercury. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2920. Implant flag: N. Life-sustain/support flag: N.

Official code: FLL. Product type: Continuous Measurement Thermometer. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2910. A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf. Implant flag: N. Life-sustain/support flag: N.

Official code: FLN. Product type: Monitor, Electric For Gravity Flow Infusion Systems. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2420. Implant flag: N. Life-sustain/support flag: N.

Official code: FLS. Product type: Monitor, Apnea, Facility Use. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2377. Implant flag: N. Life-sustain/support flag: Y.

Official code: FMA. Product type: Depressor, Tongue, Non-Surgical. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6230. Implant flag: N. Life-sustain/support flag: N.

Official code: FMC. Product type: Patient Examination Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. Implant flag: N. Life-sustain/support flag: N.

Official code: FME. Product type: Gown, Examination. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6265. Implant flag: N. Life-sustain/support flag: N.

Official code: FMF. Product type: Syringe, Piston. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. Implant flag: N. Life-sustain/support flag: N.

Official code: FMG. Product type: Stopcock, I.V. Set. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: FMH. Product type: Container, Specimen, Sterile. Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: FMI. Product type: Needle, Hypodermic, Single Lumen. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: FMJ. Product type: Manometer, Spinal-Fluid. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2500. Implant flag: N. Life-sustain/support flag: N.

Official code: FMK. Product type: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4850. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use. Implant flag: N. Life-sustain/support flag: N.

Official code: FML. Product type: Chair, Blood Donor. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6140. Implant flag: N. Life-sustain/support flag: N.

Official code: FMP. Product type: Protector, Skin Pressure. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6450. Implant flag: N. Life-sustain/support flag: N.

Official code: FMQ. Product type: Restraint, Protective. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6760. Implant flag: N. Life-sustain/support flag: N.

Official code: FMR. Product type: Device, Transfer, Patient, Manual. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6785. Implant flag: N. Life-sustain/support flag: N.

Official code: FMS. Product type: Bed, Pediatric Open Hospital. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5140. Implant flag: N. Life-sustain/support flag: N.

Official code: FMT. Product type: Warmer, Infant Radiant. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: FMW. Product type: Cover, Mattress (Medical Purposes). Official classification: Class I. Official category: General Hospital. Regulation number: 880.6190. Implant flag: N. Life-sustain/support flag: N.

Official code: FMZ. Product type: Incubator, Neonatal. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: FNC. Product type: Tent, Pediatric Aerosol. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5710. Implant flag: N. Life-sustain/support flag: N.

Official code: FNG. Product type: Lift, Patient, Ac-Powered. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: FNJ. Product type: Bed, Manual. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5120. Implant flag: N. Life-sustain/support flag: N.

Official code: FNK. Product type: Bed, Hydraulic, Adjustable Hospital. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5110. Implant flag: N. Life-sustain/support flag: N.

Official code: FNL. Product type: Bed, Ac-Powered Adjustable Hospital. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: FNM. Product type: Mattress, Air Flotation, Alternating Pressure. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: FNN. Product type: Nipple, Lambs Feeding. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5640. Implant flag: N. Life-sustain/support flag: N.

Official code: FNP. Product type: Urinal. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6730. Implant flag: N. Life-sustain/support flag: N.

Official code: FNS. Product type: Ring Cutter. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6200. Implant flag: N. Life-sustain/support flag: N.

Official code: FNW. Product type: Pad, Kelly. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: FNY. Product type: Basin, Emesis. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6730. Implant flag: N. Life-sustain/support flag: N.

Official code: FOA. Product type: Board, Cardiopulmonary. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6080. Implant flag: N. Life-sustain/support flag: N.

Official code: FOB. Product type: Bedpan. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6730. Implant flag: N. Life-sustain/support flag: N.

Official code: FOC. Product type: Bag, Urine Collection, Newborn. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: FOD. Product type: Device, Occlusion, Umbilical. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5950. Implant flag: N. Life-sustain/support flag: N.

Official code: FOG. Product type: Hood, Oxygen, Infant. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: FOH. Product type: Mattress, Water, Temperature Regulated. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5560. Implant flag: N. Life-sustain/support flag: N.

Official code: FOK. Product type: Pad, Neonatal Eye. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5270. Implant flag: N. Life-sustain/support flag: N.

Official code: FON. Product type: Bag, Drainage, With Adhesive, Ostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: FOS. Product type: Catheter, Umbilical Artery. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: FOX. Product type: Stand, Infusion. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6990. Implant flag: N. Life-sustain/support flag: N.

Official code: FOZ. Product type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: FPA. Product type: Set, Administration, Intravascular. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: FPB. Product type: Filter, Infusion Line. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: FPD. Product type: Tube, Feeding. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FPF. Product type: Bottle, Hot/Cold Water. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6085. Implant flag: N. Life-sustain/support flag: N.

Official code: FPK. Product type: Tubing, Fluid Delivery. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: FPL. Product type: Incubator, Neonatal Transport. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: FPO. Product type: Stretcher, Wheeled. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6910. Implant flag: N. Life-sustain/support flag: N.

Official code: FPP. Product type: Stretcher, Hand-Carried. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6900. Implant flag: N. Life-sustain/support flag: N.

Official code: FPS. Product type: Board, Bed. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6070. Implant flag: N. Life-sustain/support flag: N.

Official code: FPX. Product type: Strip, Adhesive, Closure, Skin. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: FPY. Product type: Sheet, Burn. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5180. Implant flag: N. Life-sustain/support flag: N.

Official code: FQA. Product type: Scale, Surgical Sponge. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2740. Implant flag: N. Life-sustain/support flag: N.

Official code: FQH. Product type: Lavage, Jet. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5475. Implant flag: N. Life-sustain/support flag: N.

Official code: FQJ. Product type: Support, Scrotal, Therapeutic. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: FQK. Product type: Binder, Perineal. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: FQL. Product type: Stocking, Medical Support (For General Medical Purposes). Official classification: Class I. Official category: General Hospital. Regulation number: 880.5780. Implant flag: N. Life-sustain/support flag: N.

Official code: FQM. Product type: Bandage, Elastic. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5075. Implant flag: N. Life-sustain/support flag: N.

Official code: FQO. Product type: Table, Operating-Room, Ac-Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4960. Implant flag: N. Life-sustain/support flag: N.

Official code: FQP. Product type: Lamp, Operating-Room. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FQZ. Product type: Thermometer, Clinical Color Change. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: FRA. Product type: Purifier, Air, Ultraviolet, Medical. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: FRC. Product type: Indicator, Biological Sterilization Process. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: FRF. Product type: Cleaner, Air, Medical Recirculating. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5045. Implant flag: N. Life-sustain/support flag: N.

Official code: FRG. Product type: Wrap, Sterilization. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6850. Implant flag: N. Life-sustain/support flag: N.

Official code: FRI. Product type: Scale, Stand-On, Patient. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: FRJ. Product type: Chair, Geriatric. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6140. Implant flag: N. Life-sustain/support flag: N.

Official code: FRK. Product type: Chair, Examination And Treatment. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6140. Implant flag: N. Life-sustain/support flag: N.

Official code: FRL. Product type: Fiber, Medical, Absorbent. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: FRN. Product type: Pump, Infusion. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: FRO. Product type: Dressing, Wound, Drug. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: FRP. Product type: Holder, Infant Position. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5680. Implant flag: N. Life-sustain/support flag: N.

Official code: FRQ. Product type: Tube, Levine. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: FRR. Product type: Chamber, Reverse Isolation, Patient Care. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5450. Implant flag: N. Life-sustain/support flag: N.

Official code: FRT. Product type: Unit, Isolation, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: FRW. Product type: Scale, Patient. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2720. Implant flag: N. Life-sustain/support flag: N.

Official code: FRZ. Product type: Device, Patient Transfer, Powered. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6775. Implant flag: N. Life-sustain/support flag: N.

Official code: FSA. Product type: Lift, Patient, Non-Ac-Powered. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: FSD. Product type: Binder, Abdominal. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: FSE. Product type: Table, Operating-Room, Manual. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: FSH. Product type: Tray, Surgical, Needle. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FSM. Product type: Tray, Surgical, Instrument. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FSO. Product type: Microscope, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4700. Implant flag: N. Life-sustain/support flag: N.

Official code: FSP. Product type: Loupe, Diagnostic/Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FSQ. Product type: Light, Surgical, Instrument. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FSR. Product type: Light, Headband, Surgical. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4335. Implant flag: N. Life-sustain/support flag: N.

Official code: FSS. Product type: Light, Surgical, Floor Standing. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FST. Product type: Light, Surgical, Fiberoptic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FSW. Product type: Light, Surgical, Endoscopic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FSX. Product type: Light, Surgical, Connector. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FSY. Product type: Light, Surgical, Ceiling Mounted. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FSZ. Product type: Light, Surgical, Carrier. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FTA. Product type: Light, Surgical, Accessories. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FTC. Product type: Light, Ultraviolet, Dermatological. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4630. Implant flag: N. Life-sustain/support flag: N.

Official code: FTD. Product type: Lamp, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FTF. Product type: Illuminator, Non-Remote. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FTG. Product type: Illuminator, Remote. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: FTH. Product type: Camera, Still, Microsurgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FTI. Product type: Lamp, Endoscope, Incandescent. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FTJ. Product type: Colonoscope, General & Plastic Surgery. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: FTL. Product type: Mesh, Surgical, Polymeric. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: FTM. Product type: Mesh, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: FTN. Product type: Plastic Surgery And Accessories Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3925. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: FTO. Product type: Prosthesis, Testicle. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.3750. Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95 Implant flag: Y. Life-sustain/support flag: N.

Official code: FTQ. Product type: Prosthesis, Penis, Rigid Rod. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.3630. Implant flag: Y. Life-sustain/support flag: N.

Official code: FTR. Product type: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.3540. Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91 Implant flag: Y. Life-sustain/support flag: N.

Official code: FTS. Product type: Camera, Cine, Endoscopic, With Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FTT. Product type: Camera, Still, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FTX. Product type: Mirror, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FTY. Product type: Tape, Measuring, Rulers And Calipers. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FTZ. Product type: Locator, Magnetic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4445. Implant flag: N. Life-sustain/support flag: N.

Official code: FWB. Product type: Camera, Television, Surgical, Without Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWC. Product type: Camera, Television, Surgical, With Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWD. Product type: Camera, Television, Microsurgical, Without Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWE. Product type: Camera, Television, Microsurgical, With Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWF. Product type: Camera, Television, Endoscopic, Without Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWG. Product type: Camera, Television, Endoscopic, With Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWH. Product type: Camera, Cine, Surgical, Without Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWI. Product type: Camera, Cine, Surgical, With Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWJ. Product type: Camera, Cine, Microsurgical, Without Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWK. Product type: Camera, Cine, Microsurgical, With Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWL. Product type: Camera, Cine, Endoscopic, Without Audio. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FWM. Product type: Prosthesis, Breast, Inflatable, Internal, Saline. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.3530. Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99 Implant flag: Y. Life-sustain/support flag: N.

Official code: FWN. Product type: Prosthesis, Larynx (Stents And Keels). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: N. Life-sustain/support flag: N.

Official code: FWP. Product type: Prosthesis, Chin, Internal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3550. Implant flag: Y. Life-sustain/support flag: N.

Official code: FWW. Product type: Table, Operating-Room, Pneumatic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4960. Implant flag: N. Life-sustain/support flag: N.

Official code: FWX. Product type: Table, Operating-Room, Mechanical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: FWY. Product type: Table, Operating-Room, Non-Electrical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: FWZ. Product type: Operating Room Accessories Table Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: FXE. Product type: Speculum, Non-Illuminated. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: FXF. Product type: Speculum, Illuminated. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: FXG. Product type: Specula Accessories. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: FXM. Product type: Camera, Still, Endoscopic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FXN. Product type: Tape, Camera, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FXO. Product type: Suit, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FXP. Product type: Cover, Shoe, Operating-Room. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FXQ. Product type: Lens, Camera, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FXR. Product type: Holder, Camera, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FXS. Product type: Frame, Camera, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FXT. Product type: Film, Camera, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: FXW. Product type: Shoes, Operating-Room. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FXX. Product type: Mask, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FXY. Product type: Hood, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FXZ. Product type: Helmet, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FYA. Product type: Gown, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FYB. Product type: Gown, Patient. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FYC. Product type: Gown, Isolation, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FYD. Product type: Apparatus, Exhaust, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: FYE. Product type: Dress, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FYF. Product type: Cap, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: FYH. Product type: Splint, Extremity, Noninflatable, External, Sterile. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: FYI. Product type: Appliance, Facial Fracture, External. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: FZC. Product type: Prosthesis, Arterial Graft, Bovine Carotid Artery. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: FZD. Product type: Prosthesis, Ear, Internal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3590. Implant flag: Y. Life-sustain/support flag: N.

Official code: FZE. Product type: Prosthesis, Nose, Internal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3680. Implant flag: Y. Life-sustain/support flag: N.

Official code: FZF. Product type: Splint, Extremity, Inflatable, External. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: FZG. Product type: Apparatus, Air Handling, Bench. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: FZH. Product type: Apparatus, Air Handling, Room. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: FZI. Product type: Apparatus, Air Handling, Enclosure. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: FZK. Product type: Chair, Surgical, Non-Electrical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: FZM. Product type: Stool, Operating-Room. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: FZO. Product type: Chisel, Surgical, Manual. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZP. Product type: Clip, Implantable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Implant flag: Y. Life-sustain/support flag: N.

Official code: FZQ. Product type: Clip, Removable (Skin). Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4320. Implant flag: N. Life-sustain/support flag: N.

Official code: FZR. Product type: Contractor, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZS. Product type: Curette, Surgical, General Use. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZT. Product type: Cutter, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZW. Product type: Expander, Surgical, Skin Graft. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZX. Product type: Guide, Surgical, Instrument. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZY. Product type: Hammer, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: FZZ. Product type: Marker, Skin. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4660. Implant flag: N. Life-sustain/support flag: N.

Official code: GAA. Product type: Needle, Aspiration And Injection, Disposable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAB. Product type: Needle, Suturing, Disposable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAC. Product type: Rasp, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAD. Product type: Retractor. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAE. Product type: Snare, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAF. Product type: Spatula, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAG. Product type: Stapler, Surgical. Official classification: Class II. Official category: General Hospital. Regulation number: 878.4740. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. Implant flag: N. Life-sustain/support flag: N.

Official code: GAH. Product type: Stylet, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAI. Product type: Stripper, Vein, Reusable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAJ. Product type: Stripper, Vein, Disposable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GAK. Product type: Suture, Absorbable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4830. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAL. Product type: Suture, Absorbable, Natural. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4830. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAM. Product type: Suture, Absorbable, Synthetic, Polyglycolic Acid. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4493. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAN. Product type: Suture, Absorbable, Synthetic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4830. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAO. Product type: Suture, Nonabsorbable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4495. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAP. Product type: Suture, Nonabsorbable, Silk. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5030. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAQ. Product type: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4495. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAR. Product type: Suture, Nonabsorbable, Synthetic, Polyamide. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5020. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAS. Product type: Suture, Nonabsorbable, Synthetic, Polyester. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5000. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAT. Product type: Suture, Nonabsorbable, Synthetic, Polyethylene. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5000. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAW. Product type: Suture, Nonabsorbable, Synthetic, Polypropylene. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5010. Implant flag: Y. Life-sustain/support flag: N.

Official code: GAX. Product type: Tourniquet, Nonpneumatic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: GAZ. Product type: Tubing, Noninvasive. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: GBA. Product type: Catheter, Balloon Type. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBB. Product type: Chair, Surgical, Ac-Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4960. Implant flag: N. Life-sustain/support flag: N.

Official code: GBC. Product type: Lamp, Surgical, Incandescent. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: GBI. Product type: Material, External Aesthetic Restoration, Used With Adhesive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: GBJ. Product type: Prosthesis, Adhesive, External. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: GBL. Product type: Catheter, Ureteral, General & Plastic Surgery. Official classification: Not classified. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: GBM. Product type: Catheter, Urethral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: GBN. Product type: Catheter, Pediatric, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBO. Product type: Catheter, Nephrostomy, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBP. Product type: Catheter, Multiple Lumen. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBQ. Product type: Catheter, Continuous Irrigation. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBS. Product type: Catheter, Ventricular, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBT. Product type: Catheter, Rectal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: GBW. Product type: Catheter, Peritoneal. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBX. Product type: Catheter, Irrigation. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBY. Product type: Catheter, Eustachian, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GBZ. Product type: Catheter, Cholangiography. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GCA. Product type: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5010. Implant flag: N. Life-sustain/support flag: N.

Official code: GCB. Product type: Needle, Catheter. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GCC. Product type: Dilator, Catheter. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GCD. Product type: Connector, Catheter. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GCE. Product type: Adaptor, Catheter. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: GCF. Product type: Proctoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCG. Product type: Peritoneoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCH. Product type: Mediastinoscope, Diagnostic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCI. Product type: Laryngoscope, Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCJ. Product type: Laparoscope, General & Plastic Surgery. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: GCK. Product type: Gastroscope, General & Plastic Surgery. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCL. Product type: Esophagoscope, General & Plastic Surgery. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: GCM. Product type: Endoscope, Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCN. Product type: Endoscope, Prism. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCO. Product type: Endoscope, Mirror. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCP. Product type: Endoscope, Ac-Powered And Accessories. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCQ. Product type: Endoscope, Flexible. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCS. Product type: Endoscope, Battery-Powered And Accessories. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCT. Product type: Light Source, Endoscope, Xenon Arc. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCW. Product type: Transformer, Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GCX. Product type: Apparatus, Suction, Operating-Room, Wall Vacuum Powered. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: GCY. Product type: Apparatus, Suction, Single Patient Use, Portable, Nonpowered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4680. Implant flag: N. Life-sustain/support flag: N.

Official code: GCZ. Product type: Retainer, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDB. Product type: Endoscope, Fiber Optic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GDC. Product type: Table, Operating-Room, Electrical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4960. Implant flag: N. Life-sustain/support flag: N.

Official code: GDF. Product type: Guide, Needle, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDG. Product type: Hook, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDH. Product type: Gouge, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDI. Product type: Dissector, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDJ. Product type: Clamp, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDL. Product type: Needle, Suturing, Reusable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDM. Product type: Needle, Aspiration And Injection, Reusable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDN. Product type: Knife, Amputation. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDO. Product type: Applier, Surgical, Clip. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDR. Product type: Saw, Manual And Accessories. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDS. Product type: Bag, Stomal. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: GDT. Product type: Staple, Removable (Skin). Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4760. Implant flag: N. Life-sustain/support flag: N.

Official code: GDW. Product type: Staple, Implantable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4750. Implant flag: Y. Life-sustain/support flag: N.

Official code: GDX. Product type: Scalpel, One-Piece. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GDY. Product type: Gauze/Sponge, Internal, X-Ray Detectable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4450. Implant flag: N. Life-sustain/support flag: N.

Official code: GDZ. Product type: Handle, Scalpel. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEA. Product type: Cannula, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEC. Product type: Brush, Scrub, Operating-Room. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GED. Product type: Brush, Dermabrasion, Manual. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEE. Product type: Brush, Biopsy, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEF. Product type: Applier, Staple, Surgical,. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEG. Product type: Elevator, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEH. Product type: Unit, Cryosurgical, Accessories. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: GEI. Product type: Electrosurgical, Cutting & Coagulation & Accessories. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: GEJ. Product type: Carrier, Ligature. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEN. Product type: Forceps, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GEO. Product type: File, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GES. Product type: Blade, Scalpel. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GET. Product type: Motor, Surgical Instrument, Pneumatic Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GEX. Product type: Powered Laser Surgical Instrument. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light. Implant flag: N. Life-sustain/support flag: N.

Official code: GEY. Product type: Motor, Surgical Instrument, Ac-Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFA. Product type: Blade, Saw, General & Plastic Surgery, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFB. Product type: Head, Surgical, Hammer. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFC. Product type: Driver, Surgical, Pin. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFD. Product type: Dermatome. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFE. Product type: Brush, Dermabrasion, Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFF. Product type: Bur, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFG. Product type: Bit, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: GFI. Product type: Osteotome, Manual. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GFJ. Product type: Mallet, Surgical, General & Plastic Surgery. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GFK. Product type: Fibrinogen Determination Standards And Controls. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: GFO. Product type: Activated Partial Thromboplastin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7925. Implant flag: N. Life-sustain/support flag: N.

Official code: GFS. Product type: Standards And Controls, Hemoglobin, Normal And Abnormal. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GFT. Product type: Protamine Sulphate. Official classification: Class II. Official category: Hematology. Regulation number: 864.7525. Implant flag: N. Life-sustain/support flag: N.

Official code: GFX. Product type: Fibrinogen Standard. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: GGC. Product type: Control, Plasma, Abnormal. Official classification: Class II. Official category: Hematology. Regulation number: 864.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: GGF. Product type: Acid Hematin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: GGG. Product type: Guaiac Reagent. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. Implant flag: N. Life-sustain/support flag: N.

Official code: GGH. Product type: Iron Stains. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: GGJ. Product type: Fluid, Diluting, White-Cell. Official classification: Class I. Official category: Hematology. Regulation number: 864.8200. Implant flag: N. Life-sustain/support flag: N.

Official code: GGK. Product type: Products, Red-Cell Lysing Products. Official classification: Class I. Official category: Hematology. Regulation number: 864.8540. Implant flag: N. Life-sustain/support flag: N.

Official code: GGL. Product type: Control, White-Cell. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GGM. Product type: Control, Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GGN. Product type: Plasma, Coagulation Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: GGO. Product type: Reagent, Thromboplastin And Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7925. Implant flag: N. Life-sustain/support flag: N.

Official code: GGP. Product type: Test, Qualitative And Quantitative Factor Deficiency. Official classification: Class II. Official category: Hematology. Regulation number: 864.7290. Implant flag: N. Life-sustain/support flag: N.

Official code: GGQ. Product type: Test, Prothrombin Consumption. Official classification: Class II. Official category: Hematology. Regulation number: 864.7720. Implant flag: N. Life-sustain/support flag: N.

Official code: GGT. Product type: Assay, Erythropoietin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7250. Implant flag: N. Life-sustain/support flag: N.

Official code: GGW. Product type: Test, Time, Partial Thromboplastin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7925. Implant flag: N. Life-sustain/support flag: N.

Official code: GGX. Product type: Pipette, Sahli. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GGY. Product type: Pipette, Diluting. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GGZ. Product type: Oxyhemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: GHA. Product type: Hemoglobin, Alkali Resistant. Official classification: Class II. Official category: Hematology. Regulation number: 864.7455. Implant flag: N. Life-sustain/support flag: N.

Official code: GHC. Product type: Tube, Sedimentation Rate. Official classification: Class I. Official category: Hematology. Regulation number: 864.6700. Implant flag: N. Life-sustain/support flag: N.

Official code: GHD. Product type: Test, Leukocyte Alkaline Phosphatase. Official classification: Class I. Official category: Hematology. Regulation number: 864.7660. Implant flag: N. Life-sustain/support flag: N.

Official code: GHH. Product type: Fibrin Split Products. Official classification: Class II. Official category: Hematology. Regulation number: 864.7320. Implant flag: N. Life-sustain/support flag: N.

Official code: GHK. Product type: Centrifuge, Microsedimentation. Official classification: Class I. Official category: Hematology. Regulation number: 864.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: GHM. Product type: Test, Sickle Cell. Official classification: Class II. Official category: Hematology. Regulation number: 864.7825. Implant flag: N. Life-sustain/support flag: N.

Official code: GHO. Product type: Hemocytometer. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GHQ. Product type: Stain, Fetal Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7455. Implant flag: N. Life-sustain/support flag: N.

Official code: GHR. Product type: Reagent, Platelet Aggregation. Official classification: Class II. Official category: Hematology. Regulation number: 864.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: GHS. Product type: Assay, Carboxyhemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7425. Implant flag: N. Life-sustain/support flag: N.

Official code: GHY. Product type: Hematocrit, Tube, Rack, Sealer, Holder. Official classification: Class II. Official category: Hematology. Regulation number: 864.6400. Implant flag: N. Life-sustain/support flag: N.

Official code: GHZ. Product type: Solution, Gugol Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: GIA. Product type: Test, Leukocyte Peroxidase. Official classification: Class I. Official category: Hematology. Regulation number: 864.7675. Implant flag: N. Life-sustain/support flag: N.

Official code: GIE. Product type: Fibrometer. Official classification: Class II. Official category: Hematology. Regulation number: 864.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: GIF. Product type: Diluent, Blood Cell. Official classification: Class I. Official category: Hematology. Regulation number: 864.8200. Implant flag: N. Life-sustain/support flag: N.

Official code: GIG. Product type: Hemoglobinometer. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: GII. Product type: Glutathione, Red-Cell. Official classification: Class II. Official category: Hematology. Regulation number: 864.7375. Implant flag: N. Life-sustain/support flag: N.

Official code: GIL. Product type: Plasma, Fibrinogen Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: GIM. Product type: Tubes, Vacuum Sample, With Anticoagulant. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. Implant flag: N. Life-sustain/support flag: N.

Official code: GIO. Product type: Tube, Collection, Capillary Blood. Official classification: Class I. Official category: Hematology. Regulation number: 864.6150. Implant flag: N. Life-sustain/support flag: N.

Official code: GIQ. Product type: Hemoglobin S. Official classification: Class II. Official category: Hematology. Regulation number: 864.7415. Implant flag: N. Life-sustain/support flag: N.

Official code: GIR. Product type: Reagent, Russel Viper Venom. Official classification: Class I. Official category: Hematology. Regulation number: 864.8950. Implant flag: N. Life-sustain/support flag: N.

Official code: GIS. Product type: Test, Fibrinogen. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: GIT. Product type: Reagent & Control, Partial Thromboplastin Time. Official classification: Class II. Official category: Hematology. Regulation number: 864.7925. Implant flag: N. Life-sustain/support flag: N.

Official code: GIZ. Product type: Plasma, Control, Normal. Official classification: Class II. Official category: Hematology. Regulation number: 864.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: GJA. Product type: Test, Thrombin Time. Official classification: Class II. Official category: Hematology. Regulation number: 864.7875. Implant flag: N. Life-sustain/support flag: N.

Official code: GJB. Product type: Thrombin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7875. Implant flag: N. Life-sustain/support flag: N.

Official code: GJC. Product type: Assay, Sulfhemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7490. Implant flag: N. Life-sustain/support flag: N.

Official code: GJE. Product type: Tray, Blood Collection. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. Implant flag: N. Life-sustain/support flag: N.

Official code: GJG. Product type: Pipette, Quantitative, Hematology. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GJH. Product type: Stain, Reticulocyte. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: GJJ. Product type: Stains, Heinz Body. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: GJL. Product type: Romanowsky Stains. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: GJN. Product type: Fluid, Diluting, Red-Cell. Official classification: Class I. Official category: Hematology. Regulation number: 864.8200. Implant flag: N. Life-sustain/support flag: N.

Official code: GJP. Product type: Control, Platelet. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GJR. Product type: Control, Red-Cell. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GJS. Product type: Test, Time, Prothrombin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7750. Implant flag: N. Life-sustain/support flag: N.

Official code: GJT. Product type: Plasma, Coagulation Factor Deficient. Official classification: Class II. Official category: Hematology. Regulation number: 864.7290. Implant flag: N. Life-sustain/support flag: N.

Official code: GJW. Product type: Pipette, Pasteur. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GJZ. Product type: Cyanomethemoglobin Reagent And Standard Solution. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: GKA. Product type: Abnormal Hemoglobin Quantitation. Official classification: Class II. Official category: Hematology. Regulation number: 864.7415. Implant flag: N. Life-sustain/support flag: N.

Official code: GKB. Product type: Device, Automated Sedimentation Rate. Official classification: Class I. Official category: Hematology. Regulation number: 864.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: GKE. Product type: Osmotic Fragility Testing. Official classification: Class I. Official category: Hematology. Regulation number: 864.6600. Implant flag: N. Life-sustain/support flag: N.

Official code: GKF. Product type: Instrument, Hematocrit, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5600. Implant flag: N. Life-sustain/support flag: N.

Official code: GKG. Product type: Centrifuge, Hematocrit. Official classification: Class II. Official category: Hematology. Regulation number: 864.6400. Implant flag: N. Life-sustain/support flag: N.

Official code: GKH. Product type: Apparatus, Automated Blood Cell Diluting. Official classification: Class I. Official category: Hematology. Regulation number: 864.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: GKJ. Product type: Spinner, Slide, Automated. Official classification: Class I. Official category: Hematology. Regulation number: 864.5850. Implant flag: N. Life-sustain/support flag: N.

Official code: GKK. Product type: Cyanomethemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: GKL. Product type: Counter, Cell, Automated (Particle Counter). Official classification: Class II. Official category: Hematology. Regulation number: 864.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: GKM. Product type: Hand-Tally, Differential. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GKN. Product type: Timer, Clot, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: GKP. Product type: Instrument, Coagulation, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: GKQ. Product type: Test, Thromboplastin Generation. Official classification: Class I. Official category: Hematology. Regulation number: 864.7900. Implant flag: N. Life-sustain/support flag: N.

Official code: GKR. Product type: System, Hemoglobin, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5620. Implant flag: N. Life-sustain/support flag: N.

Official code: GKT. Product type: Separator, Automated, Blood Cell, Diagnostic. Official classification: Class II. Official category: Hematology. Regulation number: 864.9245. Implant flag: N. Life-sustain/support flag: N.

Official code: GKW. Product type: Aggregometer, Platelet, Thrombokinetogram. Official classification: Class II. Official category: Hematology. Regulation number: 864.6675. Implant flag: N. Life-sustain/support flag: N.

Official code: GKX. Product type: Instrument, Automated Platelet Counting. Official classification: Class II. Official category: Hematology. Regulation number: 864.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: GKZ. Product type: Counter, Differential Cell. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: GLE. Product type: Mixer, Blood Tube. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: GLG. Product type: Platelet Counting, Manual. Official classification: Class I. Official category: Hematology. Regulation number: 864.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: GLK. Product type: Control, Hematocrit. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GLQ. Product type: Mixture, Control, White-Cell And Red-Cell Indices. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: GLY. Product type: Oximeter To Measure Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: GLZ. Product type: Antigens, If, Toxoplasma Gondii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: GMA. Product type: Antisera, Fluorescent, Sporothrix Schenekii. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: GMB. Product type: Light, Wood'S, Fluorescence. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2600. Implant flag: N. Life-sustain/support flag: N.

Official code: GMD. Product type: Antisera, Latex Agglutination, Cryptococcus Neoformans. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: GME. Product type: Antisera, Fluorescent, Cryptococcus Neoformans. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: GMG. Product type: Antigen, Latex Agglutination, Coccidioides Immitis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3135. Implant flag: N. Life-sustain/support flag: N.

Official code: GMH. Product type: Antiserum, Positive Control, Coccidioides Immitis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3135. Implant flag: N. Life-sustain/support flag: N.

Official code: GMI. Product type: Antigen, Cf And / Or Id, Coccidioides Immitis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3135. Implant flag: N. Life-sustain/support flag: N.

Official code: GMJ. Product type: Antigens, Histoplasma Capsulatum, All. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: GMK. Product type: Antiserum, Positive Control, Histoplasma Capsulatum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: GML. Product type: Antisera, Fluorescent, Histoplasma Capsulatum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: GMM. Product type: Antigens, Iha, Toxoplasma Gondii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: GMN. Product type: Antigens, Cf, Toxoplasma Gondii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: GMO. Product type: Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: GMP. Product type: Antisera, Control For Nontreponemal Tests. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3820. Implant flag: N. Life-sustain/support flag: N.

Official code: GMQ. Product type: Antigens, Nontreponemal, All. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3820. Implant flag: N. Life-sustain/support flag: N.

Official code: GMR. Product type: Sera, Reactive And Non-Specific Control, Fta-Abs Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: GMS. Product type: Anti-Human Globulin, Fta-Abs Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: GMT. Product type: Antigens, Ha, Treponema Pallidum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: GMW. Product type: Test, Sorbent, Fta-Abs. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: GMX. Product type: Antisera, Fluorescent Antibody For Fta-Abs Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: GMY. Product type: Antisera, Fluorescent, All Types, Escherichia Coli. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3255. Implant flag: N. Life-sustain/support flag: N.

Official code: GMZ. Product type: Antigens, All Types, Escherichia Coli. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3255. Implant flag: N. Life-sustain/support flag: N.

Official code: GNA. Product type: Antisera, All Types, Escherichia Coli. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3255. Implant flag: N. Life-sustain/support flag: N.

Official code: GNB. Product type: Antisera, All Types, Shigella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: GNC. Product type: Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: GND. Product type: Antigen, Iha, T. Cruzi. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: GNE. Product type: Antigen, Latex Agglutination, T. Cruzi. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: GNF. Product type: Antigen, Cf, T. Cruzi. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: GNG. Product type: Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3145. Implant flag: N. Life-sustain/support flag: N.

Official code: GNH. Product type: Antigen, Fluorescent Antibody Test, Schistosoma Mansoni. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: GNI. Product type: Antisera, Neutralization, Echovirus 1-34. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3205. Implant flag: N. Life-sustain/support flag: N.

Official code: GNJ. Product type: Antigens, Ha, Echovirus 1-34. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3205. Implant flag: N. Life-sustain/support flag: N.

Official code: GNK. Product type: Antisera, Cf, Echovirus 1-34. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3205. Implant flag: N. Life-sustain/support flag: N.

Official code: GNL. Product type: Antigens, Cf (Including Cf Control), Echovirus 1-34. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3205. Implant flag: N. Life-sustain/support flag: N.

Official code: GNM. Product type: Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3145. Implant flag: N. Life-sustain/support flag: N.

Official code: GNN. Product type: Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3145. Implant flag: N. Life-sustain/support flag: N.

Official code: GNO. Product type: Antisera, Cf, Coxsackievirus A 1-24, B 1-6. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3145. Implant flag: N. Life-sustain/support flag: N.

Official code: GNP. Product type: Antiserum, Cf, Epstein-Barr Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: GNQ. Product type: Antigen, Cf (Including Cf Control), Epstein-Barr Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: GNR. Product type: Antisera, Neutralization, Influenza Virus A, B, C. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: GNS. Product type: Antisera, Hai, Influenza Virus A, B, C. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: GNT. Product type: Antigens, Ha (Including Ha Control), Influenza Virus A, B, C. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: GNW. Product type: Antisera, Cf, Influenza Virus A, B, C. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: GNX. Product type: Antigens, Cf (Including Cf Control), Influenza Virus A, B, C. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: GNY. Product type: Antisera, Fluorescent, Adenovirus 1-33. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3020. Implant flag: N. Life-sustain/support flag: N.

Official code: GNZ. Product type: Antisera, Neutralization, Adenovirus 1-33. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3020. Implant flag: N. Life-sustain/support flag: N.

Official code: GOA. Product type: Antisera, Cf, Adenovirus 1-33. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3020. Implant flag: N. Life-sustain/support flag: N.

Official code: GOB. Product type: Antigens, Ha (Including Ha Control), Adenovirus 1-33. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3020. Implant flag: N. Life-sustain/support flag: N.

Official code: GOC. Product type: Antisera, Hai, Adenovirus 1-33. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3020. Implant flag: N. Life-sustain/support flag: N.

Official code: GOD. Product type: Antigens, Cf (Including Cf Control), Adenovirus 1-33. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3020. Implant flag: N. Life-sustain/support flag: N.

Official code: GOE. Product type: Antisera, Fluorescent, Poliovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3405. Implant flag: N. Life-sustain/support flag: N.

Official code: GOF. Product type: Antisera, Neutralization, Poliovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3405. Implant flag: N. Life-sustain/support flag: N.

Official code: GOG. Product type: Antisera, Cf, Poliovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3405. Implant flag: N. Life-sustain/support flag: N.

Official code: GOH. Product type: Antigens, Cf (Including Cf Control), Poliovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3405. Implant flag: N. Life-sustain/support flag: N.

Official code: GOI. Product type: Antiserum, Fluorescent, Rabies Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3460. Implant flag: N. Life-sustain/support flag: N.

Official code: GOJ. Product type: Antisera, Neutralization, Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: GOK. Product type: Antisera, Hai (Including Hai Control), Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: GOL. Product type: Antigen, Ha (Including Ha Control), Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: GOM. Product type: Antisera, Cf, Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: GON. Product type: Antigen, Cf (Including Cf Control), Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: GOO. Product type: Antisera, Fluorescent, All Globulins, Salmonella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: GOP. Product type: Antisera, C. Acnes (553, 605). Official classification: Class I. Official category: Microbiology. Regulation number: 866.3140. Implant flag: N. Life-sustain/support flag: N.

Official code: GOS. Product type: Antiserum, Fluorescent, C. Diphtheriae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3140. Implant flag: N. Life-sustain/support flag: N.

Official code: GOT. Product type: Antigen, B. Parapertussis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3065. Implant flag: N. Life-sustain/support flag: N.

Official code: GOW. Product type: Antisera, Agglutinating, B. Parapertussis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3065. Implant flag: N. Life-sustain/support flag: N.

Official code: GOX. Product type: Antigen, B. Pertussis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3065. Implant flag: N. Life-sustain/support flag: N.

Official code: GOY. Product type: Antisera, Agglutinating, B. Pertussis, All. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3065. Implant flag: N. Life-sustain/support flag: N.

Official code: GOZ. Product type: Antisera, Fluorescent, B. Pertussis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3065. Implant flag: N. Life-sustain/support flag: N.

Official code: GPD. Product type: Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: GPE. Product type: Antisera, Positive Control, Echinococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: GPF. Product type: Antigen, Agglutinating, Echinococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: GPG. Product type: Antigen, Latex Agglutination, Trichinella Spiralis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: GPH. Product type: Antiserum, Bentonite Flocculation, Trichinella Spiralis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: GPI. Product type: Antigen, Bentonite Flocculation, Trichinella Spiralis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: GPJ. Product type: Antiserum, Fluorescent, Q Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPK. Product type: Antiserum, Rickettsial Pox. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPM. Product type: Antiserum, Murine Typhus Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPN. Product type: Antiserum, Typhus Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPO. Product type: Antigen, Cf, Typhus Fever Group. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPP. Product type: Antiserum, Rocky Mountain Spotted Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPQ. Product type: Antigen, Cf, Spotted Fever Group. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPR. Product type: Antiserum, Cf, Q Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPS. Product type: Antigen, Cf, Q Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: GPT. Product type: Antiserum, Cf, Psittacosis (Chlamydia Group). Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: GPW. Product type: Antigen, Cf, Psittacosis (Chlamydia Group). Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: GPX. Product type: Antisera, Neutralizion, Reovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3470. Implant flag: N. Life-sustain/support flag: N.

Official code: GPY. Product type: Antisera, Hai, Reovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3470. Implant flag: N. Life-sustain/support flag: N.

Official code: GPZ. Product type: Antisera, Cf, Reovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3470. Implant flag: N. Life-sustain/support flag: N.

Official code: GQA. Product type: Antigens, Ha (Including Ha Control), Reovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3470. Implant flag: N. Life-sustain/support flag: N.

Official code: GQB. Product type: Antigens, Cf (Including Cf Control), Reovirus 1-3. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3470. Implant flag: N. Life-sustain/support flag: N.

Official code: GQC. Product type: Antisera, Cf, Equine Encephalitis Virus, Eee, Wee. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: GQD. Product type: Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3240. Implant flag: N. Life-sustain/support flag: N.

Official code: GQE. Product type: Antisera, Neutralization, All Types, Rhinovirus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: GQF. Product type: Antiserum, Neutralization, Respiratory Syncytial Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3480. Implant flag: N. Life-sustain/support flag: N.

Official code: GQG. Product type: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3480. Implant flag: N. Life-sustain/support flag: N.

Official code: GQH. Product type: Antigen, Cf (Including Cf Control), Cytomegalovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: GQI. Product type: Antiserum, Cf, Cytomegalovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: GQJ. Product type: Antiserum, Cf, Lymphocytic Choriomeningitis Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3360. Implant flag: N. Life-sustain/support flag: N.

Official code: GQK. Product type: Antigen, Cf, Lymphocytic Choriomeningitis Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3360. Implant flag: N. Life-sustain/support flag: N.

Official code: GQL. Product type: Antisera, Fluorescent, Herpesvirus Hominis 1,2. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: GQM. Product type: Antisera, Neutralization, Herpesvirus Hominis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: GQN. Product type: Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: GQO. Product type: Antisera, Cf, Herpesvirus Hominis 1,2. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: GQP. Product type: Antisera, Neutralization, Parainfluenza Virus 1-4. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: GQQ. Product type: Antisera, Hai, Parainfluenza Virus 1-4. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: GQR. Product type: Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: GQS. Product type: Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: GQT. Product type: Antisera, Cf, Parainfluenza Virus 1-4. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: GQW. Product type: Antigen, Cf, (Including Cf Control), Varicella-Zoster. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: GQX. Product type: Antiserum, Cf, Varicella-Zoster. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: GQY. Product type: Antigen, Ha (Including Ha Control), Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: GQZ. Product type: Antiserum, Neutralization, Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: GRA. Product type: Antiserum, Fluorescent, Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: GRB. Product type: Antiserum, Cf, Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: GRC. Product type: Antigen, Cf (Including Cf Control), Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: GRD. Product type: Antiserum, Hai, Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: GRE. Product type: Antiserum, Fluorescent, Rubeola. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: GRF. Product type: Antiserum, Cf, Rubeola. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: GRG. Product type: Antiserum, Hai, Rubeola. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: GRH. Product type: Antigen, Ha (Including Ha Control), Rubeola. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: GRI. Product type: Antiserum, Neutralization, Rubeola. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: GRJ. Product type: Antigen, Cf, (Including Cf Control), Rubeola. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: GRK. Product type: Antisera, Fluorescent, Echovirus 1-34. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3205. Implant flag: N. Life-sustain/support flag: N.

Official code: GRL. Product type: Antigens, All Groups, Salmonella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: GRM. Product type: Antisera, All Groups, Salmonella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: GRO. Product type: Antisera, Fluorescent, All Types, Hemophilus Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: GRP. Product type: Antisera, All Types, H. Influenza. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: GRT. Product type: Antiserum, Fluorescent, Mycobacterium Tuberculosis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3370. Implant flag: N. Life-sustain/support flag: N.

Official code: GRW. Product type: Antisera, All Fluorescent, Leptospira Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: GRX. Product type: Antisera, All Leptospira Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: GRY. Product type: Antigens, All, Leptospira Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: GRZ. Product type: Antisera, Fluorescent, All, Mycoplasma Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3375. Implant flag: N. Life-sustain/support flag: N.

Official code: GSA. Product type: Antisera, All Mycoplasma Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3375. Implant flag: N. Life-sustain/support flag: N.

Official code: GSB. Product type: Antigens, Cf, All, Mycoplasma Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3375. Implant flag: N. Life-sustain/support flag: N.

Official code: GSD. Product type: Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: GSE. Product type: Antiserum, Erysipelothrix Rhusiopathiae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: GSF. Product type: Antigen, Erysipelothrix Rhusiopathiae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: GSG. Product type: Antisera, Fluorescent, All Types, Listeria Monocytogenes. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3355. Implant flag: N. Life-sustain/support flag: N.

Official code: GSH. Product type: Antisera, All Types, Listeria Monocytogenes. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3355. Implant flag: N. Life-sustain/support flag: N.

Official code: GSI. Product type: Antigens, Slide And Tube, All Types, Listeria Monocytogenes. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3355. Implant flag: N. Life-sustain/support flag: N.

Official code: GSJ. Product type: Antiserum, Fluorescent, Francisella Tularensis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: GSK. Product type: Antiserum, Francisella Tularensis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: GSL. Product type: Antigens, Slide And Tube, Francisella Tularensis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: GSM. Product type: Antisera, Fluorescent, Brucella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3085. Implant flag: N. Life-sustain/support flag: N.

Official code: GSN. Product type: Antiserum, Positive And Negative Febrile Antigen Control Serum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3085. Implant flag: N. Life-sustain/support flag: N.

Official code: GSO. Product type: Antigens (Febrile), Agglutination, Brucella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3085. Implant flag: N. Life-sustain/support flag: N.

Official code: GSP. Product type: Antiserum, Fluorescent, Campylobacter Fetus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: GSQ. Product type: Antiserum, Vibrio Cholerae, All Varieties. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3930. Implant flag: N. Life-sustain/support flag: N.

Official code: GSR. Product type: Antisera, Fluorescent, Pseudomonas Pseudomallei. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3415. Implant flag: N. Life-sustain/support flag: N.

Official code: GSS. Product type: Antisera, Fluorescent, Pseudomonas Aeruginosa. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3415. Implant flag: N. Life-sustain/support flag: N.

Official code: GST. Product type: Antiserum, Pseudomonas Pseudomallei. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3415. Implant flag: N. Life-sustain/support flag: N.

Official code: GSW. Product type: Antiserum, Flavobacterium Meningosepticum, All Groups. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3270. Implant flag: N. Life-sustain/support flag: N.

Official code: GSX. Product type: Antisera, Acinetobacter Calcoaceticus, All Varieties. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: GSY. Product type: Antisera, Fluorescent, All Globulins, Proteus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: GSZ. Product type: Antigens, Febrile (Weil-Felix), All Groups. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: GTA. Product type: Antisera, All, Serratia Marcesans. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3630. Implant flag: N. Life-sustain/support flag: N.

Official code: GTB. Product type: Antisera, Fluorescent, All Types, Klebsiella Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3340. Implant flag: N. Life-sustain/support flag: N.

Official code: GTC. Product type: Antisera, All Types, Klebsiella Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3340. Implant flag: N. Life-sustain/support flag: N.

Official code: GTD. Product type: Antisera, Fluorescent, All Globulins, Shigella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: GTE. Product type: Antisera, Arizona Spp., All. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3035. Implant flag: N. Life-sustain/support flag: N.

Official code: GTF. Product type: Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3125. Implant flag: N. Life-sustain/support flag: N.

Official code: GTH. Product type: Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3390. Implant flag: N. Life-sustain/support flag: N.

Official code: GTI. Product type: Antisera, Fluorescent, All Groups, N. Meningitidis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3390. Implant flag: N. Life-sustain/support flag: N.

Official code: GTJ. Product type: Antisera, All Groups, N. Meningitidis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3390. Implant flag: N. Life-sustain/support flag: N.

Official code: GTL. Product type: Phages, Staphylococcal Typing, All Types. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: GTN. Product type: Antisera, Fluorescent, All Types, Staphylococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: GTO. Product type: Anti-Streptokinase. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3720. Implant flag: N. Life-sustain/support flag: N.

Official code: GTP. Product type: Exoenzymes, Multiple, Streptococcal. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3720. Implant flag: N. Life-sustain/support flag: N.

Official code: GTQ. Product type: Antistreptolysin - Titer/Streptolysin O Reagent. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3720. Implant flag: N. Life-sustain/support flag: N.

Official code: GTR. Product type: Antideoxyribonuclease, Streptococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3720. Implant flag: N. Life-sustain/support flag: N.

Official code: GTX. Product type: Antisera, Fluorescent, All Groups, Streptococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: GTY. Product type: Antigens, All Groups, Streptococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: GTZ. Product type: Antisera, All Groups, Streptococcus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: GWB. Product type: Antisera, Fluorescent, All Types, Streptococcus Pneumoniae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: GWC. Product type: Antisera, All Types, Streptococcus Pneumoniae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: GWD. Product type: Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: GWE. Product type: Stimulator, Photic, Evoked Response. Official classification: Class II. Official category: Neurology. Regulation number: 882.1890. Implant flag: N. Life-sustain/support flag: N.

Official code: GWF. Product type: Stimulator, Electrical, Evoked Response. Official classification: Class II. Official category: Neurology. Regulation number: 882.1870. Implant flag: N. Life-sustain/support flag: N.

Official code: GWG. Product type: Endoscope, Neurological. Official classification: Class II. Official category: Neurology. Regulation number: 882.1480. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: GWI. Product type: Discriminator, Two-Point. Official classification: Class I. Official category: Neurology. Regulation number: 882.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: GWJ. Product type: Stimulator, Auditory, Evoked Response. Official classification: Class II. Official category: Neurology. Regulation number: 882.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: GWK. Product type: Conditioner, Signal, Physiological. Official classification: Class II. Official category: Neurology. Regulation number: 882.1845. Implant flag: N. Life-sustain/support flag: N.

Official code: GWL. Product type: Amplifier, Physiological Signal. Official classification: Class II. Official category: Neurology. Regulation number: 882.1835. Implant flag: N. Life-sustain/support flag: N.

Official code: GWM. Product type: Device, Monitoring, Intracranial Pressure. Official classification: Class II. Official category: Neurology. Regulation number: 882.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: GWN. Product type: Nystagmograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1460. Implant flag: N. Life-sustain/support flag: N.

Official code: GWO. Product type: Plate, Cranioplasty, Preformed, Alterable. Official classification: Class II. Official category: Neurology. Regulation number: 882.5320. Implant flag: Y. Life-sustain/support flag: N.

Official code: GWQ. Product type: Full-Montage Standard Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations Implant flag: N. Life-sustain/support flag: N.

Official code: GWR. Product type: Generator, Electroencephalograph Test Signal. Official classification: Class I. Official category: Neurology. Regulation number: 882.1430. Implant flag: N. Life-sustain/support flag: N.

Official code: GWS. Product type: Analyzer, Spectrum, Electroencephalogram Signal. Official classification: Class I. Official category: Neurology. Regulation number: 882.1420. Implant flag: N. Life-sustain/support flag: N.

Official code: GWW. Product type: Ataxiagraph. Official classification: Class I. Official category: Neurology. Regulation number: 882.1030. Exemption is limited to devices that do not provide an interpretation or a clinical implication of the measurement. Implant flag: N. Life-sustain/support flag: N.

Official code: GWX. Product type: Fork, Tuning. Official classification: Class I. Official category: Neurology. Regulation number: 882.1525. Implant flag: N. Life-sustain/support flag: N.

Official code: GWY. Product type: Pinwheel. Official classification: Class I. Official category: Neurology. Regulation number: 882.1750. Implant flag: N. Life-sustain/support flag: N.

Official code: GWZ. Product type: Percussor. Official classification: Class I. Official category: Neurology. Regulation number: 882.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: GXB. Product type: Esthesiometer. Official classification: Class I. Official category: Neurology. Regulation number: 882.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: GXC. Product type: Device, Electroconvulsive Therapy. Official classification: Class III. Official category: Neurology. Regulation number: 882.5940. Implant flag: N. Life-sustain/support flag: N.

Official code: GXD. Product type: Generator, Lesion, Radiofrequency. Official classification: Class II. Official category: Neurology. Regulation number: 882.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: GXE. Product type: Leukotome. Official classification: Class I. Official category: Neurology. Regulation number: 882.4600. Implant flag: N. Life-sustain/support flag: N.

Official code: GXH. Product type: Device, Surgical, Cryogenic. Official classification: Class II. Official category: Neurology. Regulation number: 882.4250. Implant flag: N. Life-sustain/support flag: N.

Official code: GXI. Product type: Probe, Radiofrequency Lesion. Official classification: Class II. Official category: Neurology. Regulation number: 882.4725. Implant flag: N. Life-sustain/support flag: N.

Official code: GXJ. Product type: Punch, Skull. Official classification: Class I. Official category: Neurology. Regulation number: 882.4750. Implant flag: N. Life-sustain/support flag: N.

Official code: GXL. Product type: Screwdriver, Skullplate. Official classification: Class I. Official category: Neurology. Regulation number: 882.4900. Implant flag: N. Life-sustain/support flag: N.

Official code: GXM. Product type: Anvil, Skull Plate. Official classification: Class I. Official category: Neurology. Regulation number: 882.4030. Implant flag: N. Life-sustain/support flag: N.

Official code: GXN. Product type: Plate, Cranioplasty, Preformed, Non-Alterable. Official classification: Class II. Official category: Neurology. Regulation number: 882.5330. Implant flag: Y. Life-sustain/support flag: N.

Official code: GXO. Product type: Strip, Craniosynostosis, Preformed. Official classification: Class II. Official category: Neurology. Regulation number: 882.5900. Implant flag: Y. Life-sustain/support flag: N.

Official code: GXP. Product type: Methyl Methacrylate For Cranioplasty. Official classification: Class II. Official category: Neurology. Regulation number: 882.5300. Implant flag: Y. Life-sustain/support flag: N.

Official code: GXQ. Product type: Dura Substitute. Official classification: Class II. Official category: Neurology. Regulation number: 882.5910. Implant flag: Y. Life-sustain/support flag: N.

Official code: GXR. Product type: Cover, Burr Hole. Official classification: Class II. Official category: Neurology. Regulation number: 882.5250. Implant flag: Y. Life-sustain/support flag: N.

Official code: GXS. Product type: Monitor, Alpha. Official classification: Class II. Official category: Neurology. Regulation number: 882.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: GXT. Product type: Monitor, Lesion Temperature. Official classification: Class II. Official category: Neurology. Regulation number: 882.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: GXW. Product type: Echoencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1240. Implant flag: N. Life-sustain/support flag: N.

Official code: GXX. Product type: Block, Test, Ultrasonic Scanner Calibration. Official classification: Class I. Official category: Neurology. Regulation number: 882.1925. Implant flag: N. Life-sustain/support flag: N.

Official code: GXY. Product type: Electrode, Cutaneous. Official classification: Class II. Official category: Neurology. Regulation number: 882.1320. Implant flag: N. Life-sustain/support flag: N.

Official code: GXZ. Product type: Electrode, Needle. Official classification: Class II. Official category: Neurology. Regulation number: 882.1350. Implant flag: N. Life-sustain/support flag: N.

Official code: GYA. Product type: Tester, Electrode/Lead, Electroencephalograph. Official classification: Class I. Official category: Neurology. Regulation number: 882.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: GYB. Product type: Media, Electroconductive. Official classification: Class II. Official category: Neurology. Regulation number: 882.1275. Implant flag: N. Life-sustain/support flag: N.

Official code: GYC. Product type: Electrode, Cortical. Official classification: Class II. Official category: Neurology. Regulation number: 882.1310. Implant flag: N. Life-sustain/support flag: N.

Official code: GYD. Product type: Transducer, Tremor. Official classification: Class II. Official category: Neurology. Regulation number: 882.1950. Implant flag: N. Life-sustain/support flag: N.

Official code: GYE. Product type: Encephalogram Telemetry System. Official classification: Class II. Official category: Neurology. Regulation number: 882.1855. Implant flag: N. Life-sustain/support flag: N.

Official code: GYK. Product type: Instrument, Shunt System Implantation. Official classification: Class I. Official category: Neurology. Regulation number: 882.4545. Implant flag: N. Life-sustain/support flag: N.

Official code: GYZ. Product type: Stimulator, Intracerebral/Subcortical, Implanted. Official classification: Class III. Official category: Neurology. Regulation number: 882.5840. Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88 Implant flag: Y. Life-sustain/support flag: N.

Official code: GZA. Product type: Implanted Cerebellar Stimulator. Official classification: Class III. Official category: Neurology. Regulation number: 882.5820. Call for pmas 9/26/84 per 49 fr 26574 on 6/28/84 Implant flag: Y. Life-sustain/support flag: N.

Official code: GZB. Product type: Stimulator, Spinal-Cord, Implanted (Pain Relief). Official classification: Class II. Official category: Neurology. Regulation number: 882.5880. Implant flag: Y. Life-sustain/support flag: N.

Official code: GZC. Product type: Stimulator, Neuromuscular, Implanted. Official classification: Class III. Official category: Neurology. Regulation number: 882.5860. Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99 Implant flag: Y. Life-sustain/support flag: N.

Official code: GZD. Product type: Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation. Official classification: Class III. Official category: Neurology. Regulation number: 882.5850. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: GZE. Product type: Implanted Diaphragmatic/Phrenic Nerve Stimulator. Official classification: Class III. Official category: Neurology. Regulation number: 882.5830. Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86 Implant flag: Y. Life-sustain/support flag: N.

Official code: GZF. Product type: Stimulator, Peripheral Nerve, Implanted (Pain Relief). Official classification: Class II. Official category: Neurology. Regulation number: 882.5870. Implant flag: Y. Life-sustain/support flag: N.

Official code: GZI. Product type: Stimulator, Neuromuscular, External Functional. Official classification: Class II. Official category: Neurology. Regulation number: 882.5810. Implant flag: N. Life-sustain/support flag: N.

Official code: GZJ. Product type: Stimulator, Nerve, Transcutaneous, For Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: GZK. Product type: Electrode, Nasopharyngeal. Official classification: Class II. Official category: Neurology. Regulation number: 882.1340. Implant flag: N. Life-sustain/support flag: N.

Official code: GZL. Product type: Electrode, Depth. Official classification: Class II. Official category: Neurology. Regulation number: 882.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: GZM. Product type: Analyzer, Rigidity. Official classification: Class II. Official category: Neurology. Regulation number: 882.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: GZN. Product type: Rheoencephalograph. Official classification: Class III. Official category: Neurology. Regulation number: 882.1825. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: GZO. Product type: Device, Galvanic Skin Response Measurement. Official classification: Class II. Official category: Neurology. Regulation number: 882.1540. Implant flag: N. Life-sustain/support flag: N.

Official code: GZP. Product type: Stimulator, Mechanical, Evoked Response. Official classification: Class II. Official category: Neurology. Regulation number: 882.1880. Implant flag: N. Life-sustain/support flag: N.

Official code: GZQ. Product type: Instrument, Dowel Cutting. Official classification: Class II. Official category: Neurology. Regulation number: 882.4275. Implant flag: N. Life-sustain/support flag: N.

Official code: GZT. Product type: Retractor, Self-Retaining, For Neurosurgery. Official classification: Class II. Official category: Neurology. Regulation number: 882.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: GZX. Product type: Instrument, Microsurgical. Official classification: Class I. Official category: Neurology. Regulation number: 882.4525. Implant flag: N. Life-sustain/support flag: N.

Official code: HAB. Product type: Saw, Powered, And Accessories. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: HAD. Product type: Rongeur, Powered. Official classification: Class II. Official category: Neurology. Regulation number: 882.4845. Implant flag: N. Life-sustain/support flag: N.

Official code: HAE. Product type: Rongeur, Manual. Official classification: Class II. Official category: Neurology. Regulation number: 882.4840. Implant flag: N. Life-sustain/support flag: N.

Official code: HAM. Product type: Apparatus, Electrosurgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: HAO. Product type: Instrument, Surgical, Non-Powered. Official classification: Class I. Official category: Neurology. Regulation number: 882.4535. Implant flag: N. Life-sustain/support flag: N.

Official code: HAS. Product type: Needle, Neurosurgical Suture. Official classification: Class I. Official category: Neurology. Regulation number: 882.4650. Implant flag: N. Life-sustain/support flag: N.

Official code: HAW. Product type: Neurological Stereotaxic Instrument. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Implant flag: N. Life-sustain/support flag: N.

Official code: HAX. Product type: Tong, Skull For Traction. Official classification: Class II. Official category: Neurology. Regulation number: 882.5960. Implant flag: N. Life-sustain/support flag: N.

Official code: HBA. Product type: Neurosurgical Paddie. Official classification: Class II. Official category: Neurology. Regulation number: 882.4700. Implant flag: N. Life-sustain/support flag: N.

Official code: HBB. Product type: Motor, Drill, Pneumatic. Official classification: Class II. Official category: Neurology. Regulation number: 882.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: HBC. Product type: Motor, Drill, Electric. Official classification: Class II. Official category: Neurology. Regulation number: 882.4360. Implant flag: N. Life-sustain/support flag: N.

Official code: HBD. Product type: Handpiece (Brace), Drill. Official classification: Class I. Official category: Neurology. Regulation number: 882.4325. Implant flag: N. Life-sustain/support flag: N.

Official code: HBE. Product type: Drills, Burrs, Trephines & Accessories (Simple, Powered). Official classification: Class II. Official category: Neurology. Regulation number: 882.4310. Implant flag: N. Life-sustain/support flag: N.

Official code: HBF. Product type: Drills, Burrs, Trephines & Accessories (Compound, Powered). Official classification: Class II. Official category: Neurology. Regulation number: 882.4305. Implant flag: N. Life-sustain/support flag: N.

Official code: HBG. Product type: Drills, Burrs, Trephines & Accessories (Manual). Official classification: Class II. Official category: Neurology. Regulation number: 882.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: HBI. Product type: Illuminator, Fiberoptic, Surgical Field. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: HBK. Product type: Chair, Pneumoencephalographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1820. Implant flag: N. Life-sustain/support flag: N.

Official code: HBL. Product type: Holder, Head, Neurosurgical (Skull Clamp). Official classification: Class II. Official category: Neurology. Regulation number: 882.4460. Implant flag: N. Life-sustain/support flag: N.

Official code: HBM. Product type: Headrest, Neurosurgical. Official classification: Class I. Official category: Neurology. Regulation number: 882.4440. Implant flag: N. Life-sustain/support flag: N.

Official code: HBN. Product type: Chair, Neurosurgical. Official classification: Class I. Official category: Neurology. Regulation number: 882.4125. Implant flag: N. Life-sustain/support flag: N.

Official code: HBO. Product type: Clip, Scalp. Official classification: Class II. Official category: Neurology. Regulation number: 882.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: HBP. Product type: Clip, Implanted Malleable. Official classification: Class II. Official category: Neurology. Regulation number: 882.5225. Implant flag: Y. Life-sustain/support flag: N.

Official code: HBQ. Product type: Instrument, Clip Removal. Official classification: Class I. Official category: Neurology. Regulation number: 882.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: HBR. Product type: Rack, Clip. Official classification: Class I. Official category: Neurology. Regulation number: 882.4215. Implant flag: N. Life-sustain/support flag: N.

Official code: HBS. Product type: Instrument, Clip Forming/Cutting. Official classification: Class I. Official category: Neurology. Regulation number: 882.4190. Implant flag: N. Life-sustain/support flag: N.

Official code: HBT. Product type: Applier, Hemostatic Clip. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HBW. Product type: Fastener, Plate, Cranioplasty. Official classification: Class II. Official category: Neurology. Regulation number: 882.5360. Implant flag: Y. Life-sustain/support flag: N.

Official code: HBX. Product type: Instrument, Cranioplasty Material Forming. Official classification: Class I. Official category: Neurology. Regulation number: 882.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: HBZ. Product type: Catheter, Intravascular Occluding. Official classification: Class III. Official category: Neurology. Regulation number: 882.5150. Call for PMAs to be filed by 12/26/96 (61 FR 50708 (9/27/96)) Implant flag: N. Life-sustain/support flag: N.

Official code: HCA. Product type: Catheter, Ventricular. Official classification: Class II. Official category: Neurology. Regulation number: 882.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: HCB. Product type: Device, Aversive Conditioning. Official classification: Class II. Official category: Neurology. Regulation number: 882.5235. Implant flag: N. Life-sustain/support flag: N.

Official code: HCC. Product type: Device, Biofeedback. Official classification: Class II. Official category: Neurology. Regulation number: 882.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: HCD. Product type: Cannula, Ventricular. Official classification: Class I. Official category: Neurology. Regulation number: 882.4060. Implant flag: N. Life-sustain/support flag: N.

Official code: HCE. Product type: Clamp, Carotid Artery. Official classification: Class II. Official category: Neurology. Regulation number: 882.5175. Implant flag: Y. Life-sustain/support flag: N.

Official code: HCF. Product type: Instrument, Ligature Passing And Knot Tying. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HCG. Product type: Device, Neurovascular Embolization. Official classification: Class II. Official category: Neurology. Regulation number: 882.5950. Implant flag: Y. Life-sustain/support flag: N.

Official code: HCH. Product type: Clip, Aneurysm. Official classification: Class II. Official category: Neurology. Regulation number: 882.5200. Implant flag: Y. Life-sustain/support flag: N.

Official code: HCI. Product type: Applier, Aneurysm Clip. Official classification: Class II. Official category: Neurology. Regulation number: 882.4175. Implant flag: N. Life-sustain/support flag: N.

Official code: HCJ. Product type: Device, Skin Potential Measurement. Official classification: Class II. Official category: Neurology. Regulation number: 882.1560. Implant flag: N. Life-sustain/support flag: N.

Official code: HCS. Product type: Device, Temperature Measurement, Direct Contact, Powered. Official classification: Class II. Official category: Neurology. Regulation number: 882.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: HCY. Product type: Curette, Uterine. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HCZ. Product type: Forceps, Surgical, Gynecological. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HDA. Product type: Forceps, Obstetrical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: HDB. Product type: Extractor, Vacuum, Fetal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4340. Implant flag: N. Life-sustain/support flag: N.

Official code: HDC. Product type: Tenaculum, Uterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HDD. Product type: Table, Obstetrical, Ac-Powered (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4900. Implant flag: N. Life-sustain/support flag: N.

Official code: HDE. Product type: Hook, Fibroid, Gynecological. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDF. Product type: Speculum, Vaginal, Metal. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDG. Product type: Speculum, Vaginal, Metal, Fiberoptic. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDH. Product type: Needle, Cerclage, Gynecological. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HDI. Product type: Hook, Destructive, Obstetrical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: HDJ. Product type: Scissors, Umbilical. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDK. Product type: Scissors, Episiotomy. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDL. Product type: Retractor, Vaginal. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDM. Product type: Packer, Uterine. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HDN. Product type: Dilator, Cervical, Expandable. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.4250. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: HDO. Product type: Valve, Tubal Occlusion. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5380. Call for PMAs 12/30/87 (52 FR 36883 10/1/87)) Implant flag: Y. Life-sustain/support flag: N.

Official code: HDP. Product type: Elevator, Uterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HDQ. Product type: Dilator, Cervical, Fixed Size. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HDR. Product type: Cap, Cervical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: HDT. Product type: Device, Intrauterine, Contraceptive And Introducer. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5360. Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86 Implant flag: Y. Life-sustain/support flag: N.

Official code: HDW. Product type: Diaphragm, Contraceptive (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: HDX. Product type: Dilator, Vaginal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: HDY. Product type: Dilator, Cervical, Hygroscopic-Laminaria. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4260. Implant flag: N. Life-sustain/support flag: N.

Official code: HDZ. Product type: Knife, Cervical Cone. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HEB. Product type: Tampon, Menstrual, Unscented. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5470. An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge. Implant flag: N. Life-sustain/support flag: N.

Official code: HEC. Product type: Insufflator, Vaginal. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5920. Implant flag: N. Life-sustain/support flag: N.

Official code: HED. Product type: Douche Apparatus, Vaginal, Therapeutic. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: HEE. Product type: Set, Anesthesia, Paracervical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: HEF. Product type: Binder, Breast. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: HEG. Product type: Set, Anesthesia, Pudendal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: HEH. Product type: Chamber, Decompression, Abdominal. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5225. Implant flag: N. Life-sustain/support flag: N.

Official code: HEI. Product type: Monitor, Heart-Valve Movement, Fetal, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: HEJ. Product type: Monitor, Hemic Sound, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: HEK. Product type: Monitor, Heart Sound, Fetal, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: HEL. Product type: Monitor, Heart Rate, Fetal, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: HEM. Product type: Imager, Ultrasonic Obstetric-Gynecologic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2225. Implant flag: N. Life-sustain/support flag: N.

Official code: HEN. Product type: Caliper, Fetal Head, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2225. Implant flag: N. Life-sustain/support flag: N.

Official code: HEO. Product type: Analyzer, Data, Obstetric. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2050. Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00 Implant flag: N. Life-sustain/support flag: N.

Official code: HEP. Product type: Monitor, Blood-Flow, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: HEQ. Product type: Monitor, Pressure, Arterial, Fetal, Ultrasonic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: HER. Product type: Pelvimeter, External. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HES. Product type: Insufflator, Carbon-Dioxide, Uterotubal (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: HET. Product type: Laparoscope, Gynecologic (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. Implant flag: N. Life-sustain/support flag: N.

Official code: HEW. Product type: Culdoscope (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: HEX. Product type: Colposcope (And Colpomicroscope). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: HEZ. Product type: Endoscope, Transcervical (Amnioscope)(And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: HFA. Product type: Amnioscope, Transabdominal (Fetoscope) (And Accessories). Official classification: HDE. Official category: Obstetrics/Gynecology. Regulation number: 884.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: HFB. Product type: Forceps, Biopsy, Gynecological. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HFC. Product type: Aspirator, Endocervical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: HFD. Product type: Washer, Endometrial. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1185. Implant flag: N. Life-sustain/support flag: N.

Official code: HFE. Product type: Brush, Endometrial. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: HFF. Product type: Aspirator, Endometrial. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1060. Implant flag: N. Life-sustain/support flag: N.

Official code: HFG. Product type: Coagulator, Laparoscopic, Unipolar (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: HFH. Product type: Coagulator, Hysteroscopic (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: HFI. Product type: Coagulator, Culdoscopic (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: HFJ. Product type: Prosthesis, Fallopian Tube. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.3650. Implant flag: Y. Life-sustain/support flag: N.

Official code: HFK. Product type: Mold, Vaginal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: HFL. Product type: Drain, Cervical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: HFM. Product type: Monitor, Uterine Contraction, External (For Use In Clinic). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2720. Implant flag: N. Life-sustain/support flag: N.

Official code: HFN. Product type: Transducer, Pressure, Intrauterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: HFO. Product type: Recorder, Pressure, Intrauterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: HFP. Product type: Monitor, Phonocardiographic, Fetal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2640. Implant flag: N. Life-sustain/support flag: N.

Official code: HFS. Product type: Shield, Nipple. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5630. Implant flag: N. Life-sustain/support flag: N.

Official code: HFW. Product type: Clamp, Umbilical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HFX. Product type: Clamp, Circumcision. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HFY. Product type: Band, Tubal Occlusion. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5380. Call for PMAs 12/30/87 (52 FR 36883 10/1/87)) Implant flag: Y. Life-sustain/support flag: N.

Official code: HFZ. Product type: Craniotribe. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: HGA. Product type: Cranioclast. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: HGB. Product type: Clip, Tubal Occlusion. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5380. Call for PMAs 12/30/87 (52 FR 36883 10/1/87)) Implant flag: Y. Life-sustain/support flag: N.

Official code: HGC. Product type: Clamp, Uterine. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HGD. Product type: Applicator, Vaginal. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: HGE. Product type: Amniotome. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HGF. Product type: Source, Abortion Unit, Vacuum. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: HGG. Product type: Controller, Abortion Unit, Vacuum. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: HGH. Product type: Cannula, Suction, Uterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: HGI. Product type: Electrocautery, Gynecologic (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4120. Implant flag: N. Life-sustain/support flag: N.

Official code: HGK. Product type: Endoscope, Fetal Blood Sampling (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: HGL. Product type: Transducer, Ultrasonic, Obstetric. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2960. Implant flag: N. Life-sustain/support flag: N.

Official code: HGM. Product type: System, Monitoring, Perinatal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2740. Implant flag: N. Life-sustain/support flag: N.

Official code: HGN. Product type: Stethoscope, Fetal. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: HGO. Product type: Monitor, Electroencephalographic, Fetal (And Accessories). Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2620. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: HGP. Product type: Electrode, Circular (Spiral), Scalp And Applicator. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2675. Implant flag: N. Life-sustain/support flag: N.

Official code: HGS. Product type: Catheter, Intrauterine And Introducer. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: HGW. Product type: Sampler, Blood, Fetal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1560. Implant flag: N. Life-sustain/support flag: N.

Official code: HGX. Product type: Pump, Breast, Powered. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: HGY. Product type: Pump, Breast, Non-Powered. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: HGZ. Product type: Heater, Perineal, Direct Contact. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5390. Implant flag: N. Life-sustain/support flag: N.

Official code: HHA. Product type: Heater, Perineal, Radiant, Non-Contact. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5390. Implant flag: N. Life-sustain/support flag: N.

Official code: HHD. Product type: Pad, Menstrual, Unscented. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5435. An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile. Implant flag: N. Life-sustain/support flag: N.

Official code: HHE. Product type: Cup, Menstrual. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5400. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow. Implant flag: N. Life-sustain/support flag: N.

Official code: HHF. Product type: Remover, Intrauterine Device, Contraceptive, Hook-Type. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HHG. Product type: Dilator, Cervical, Vibratory. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.4270. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: HHI. Product type: System, Abortion, Vacuum. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: HHJ. Product type: Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2225. Implant flag: N. Life-sustain/support flag: N.

Official code: HHK. Product type: Curette, Suction, Endometrial (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: HHL. Product type: Pad, Menstrual, Scented, Scented-Deodorized. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5425. Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b). Implant flag: N. Life-sustain/support flag: N.

Official code: HHM. Product type: Sound, Uterine. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HHN. Product type: Cleidoclast. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: HHO. Product type: Screw, Fibroid, Gynecological. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HHP. Product type: Table, Obstetrical, Manual (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4900. Implant flag: N. Life-sustain/support flag: N.

Official code: HHQ. Product type: System, Abortion, Metreurynter-Balloon. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5050. Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: HHR. Product type: Laser, Surgical, Gynecologic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4550. Implant flag: N. Life-sustain/support flag: N.

Official code: HHS. Product type: Transcervical Contraceptive Tubal Occlusion Device. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5380. Call for PMAs 12/30/87 (52 FR 36883 10/1/87)) Implant flag: Y. Life-sustain/support flag: N.

Official code: HHT. Product type: Spatula, Cervical, Cytological. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HHW. Product type: Pessary, Vaginal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.3575. Implant flag: N. Life-sustain/support flag: N.

Official code: HHX. Product type: Holograph, Fetal, Acoustical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2225. Implant flag: N. Life-sustain/support flag: N.

Official code: HHY. Product type: Prosthesis, Suture, Cerclage. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: HIB. Product type: Speculum, Vaginal, Nonmetal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HIC. Product type: Speculum, Vaginal, Nonmetal, Fiberoptic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: HIF. Product type: Insufflator, Laparoscopic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: HIG. Product type: Insufflator, Hysteroscopic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: HIH. Product type: Hysteroscope (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1690. Implant flag: N. Life-sustain/support flag: N.

Official code: HII. Product type: Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5940. Call for PMAs to be filed by 7/12/2000 per 65 FR 19834 on 4/13/00 Implant flag: N. Life-sustain/support flag: N.

Official code: HIL. Product type: Tampon, Menstrual, Scented, Scented-Deodorized. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5460. A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge. Implant flag: N. Life-sustain/support flag: N.

Official code: HIM. Product type: Electrocautery, Endoscopic And Accessories. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: HIN. Product type: Coagulator-Cutter, Endoscopic, Bipolar (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: HIO. Product type: Sampler, Amniotic Fluid (Amniocentesis Tray). Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1550. Implant flag: N. Life-sustain/support flag: N.

Official code: HIQ. Product type: Electrode, Clip, Fetal Scalp (And Applicator). Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2685. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: HIR. Product type: Perineometer. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1425. Implant flag: N. Life-sustain/support flag: N.

Official code: HIS. Product type: Condom. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: HIT. Product type: Tester, Color Vision. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: HIW. Product type: Anomaloscope. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: HIX. Product type: Maxwell Spot, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1435. Implant flag: N. Life-sustain/support flag: N.

Official code: HIY. Product type: Brush, Haidinger, (Including Macular Integrity). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1090. Implant flag: N. Life-sustain/support flag: N.

Official code: HJA. Product type: Photokeratoscope. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1350. Implant flag: N. Life-sustain/support flag: N.

Official code: HJB. Product type: Instrument, Measuring, Corneal Radius. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1450. Implant flag: N. Life-sustain/support flag: N.

Official code: HJC. Product type: Esthesiometer, Ocular. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1040. Implant flag: N. Life-sustain/support flag: N.

Official code: HJD. Product type: Illuminator, Color Vision Plate. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: HJE. Product type: Lamp, Fluorescein, Ac-Powered. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: HJF. Product type: Magnifier, Hand-Held, Low-Vision. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: HJG. Product type: System, Reading, Television, Closed-Circuit. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: HJH. Product type: Loupe, Binocular, Low Power. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5120. Implant flag: N. Life-sustain/support flag: N.

Official code: HJI. Product type: Lens, Fundus, Hruby, Diagnostic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1395. Implant flag: N. Life-sustain/support flag: N.

Official code: HJJ. Product type: Lens, Fresnel, Flexible, Diagnostic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1390. Implant flag: N. Life-sustain/support flag: N.

Official code: HJK. Product type: Lens, Contact, Polymethylmethacrylate, Diagnostic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: HJL. Product type: Lens, Condensing, Diagnostic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1380. Implant flag: N. Life-sustain/support flag: N.

Official code: HJM. Product type: Transilluminator, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1945. Implant flag: N. Life-sustain/support flag: N.

Official code: HJN. Product type: Transilluminator, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1945. Implant flag: N. Life-sustain/support flag: N.

Official code: HJO. Product type: Biomicroscope, Slit-Lamp, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HJQ. Product type: Stereoscope, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1870. Implant flag: N. Life-sustain/support flag: N.

Official code: HJR. Product type: Stereoscope, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1870. Implant flag: N. Life-sustain/support flag: N.

Official code: HJS. Product type: Test, Spectacle Dissociation, Ac-Powered (Lancaster). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1910. Implant flag: N. Life-sustain/support flag: N.

Official code: HJT. Product type: Haploscope. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1340. Implant flag: N. Life-sustain/support flag: N.

Official code: HJW. Product type: Adaptometer (Biophotometer). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: HJX. Product type: Reader, Prism, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5810. Implant flag: N. Life-sustain/support flag: N.

Official code: HJY. Product type: Reader, Bar, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: HJZ. Product type: Crutch, Ptosis. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5600. Implant flag: N. Life-sustain/support flag: N.

Official code: HKB. Product type: Telescope, Hand-Held, Low-Vision. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: HKC. Product type: Spectacle Microscope, Low-Vision. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5540. Implant flag: N. Life-sustain/support flag: N.

Official code: HKD. Product type: Tape, Nystagmus. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1905. Implant flag: N. Life-sustain/support flag: N.

Official code: HKF. Product type: Mirror, Headband, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: HKG. Product type: Fornixscope. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1320. Implant flag: N. Life-sustain/support flag: N.

Official code: HKI. Product type: Camera, Ophthalmic, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1120. Implant flag: N. Life-sustain/support flag: N.

Official code: HKK. Product type: Telescope, Spectacle, Low-Vision. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: HKL. Product type: Retinoscope, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1780. Implant flag: N. Life-sustain/support flag: N.

Official code: HKM. Product type: Retinoscope, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1780. Implant flag: N. Life-sustain/support flag: N.

Official code: HKN. Product type: Refractor, Manual, Non-Powered, Including Phoropter. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: HKO. Product type: Refractometer, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1760. Implant flag: N. Life-sustain/support flag: N.

Official code: HKP. Product type: Instrument, Vitreous Aspiration And Cutting, Battery-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: HKQ. Product type: Prism, Rotary, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1665. Implant flag: N. Life-sustain/support flag: N.

Official code: HKR. Product type: Lens, Maddox. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1400. Implant flag: N. Life-sustain/support flag: N.

Official code: HKS. Product type: Prism, Gonioscopic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: HKT. Product type: Prism, Fresnel, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1655. Implant flag: N. Life-sustain/support flag: N.

Official code: HKW. Product type: Prism, Bar, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: HKX. Product type: Tonometer, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1930. Implant flag: N. Life-sustain/support flag: N.

Official code: HKY. Product type: Tonometer, Manual. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1930. Implant flag: N. Life-sustain/support flag: N.

Official code: HKZ. Product type: Sterilizer, Tonometer. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1940. Implant flag: N. Life-sustain/support flag: N.

Official code: HLA. Product type: Calibrator, Tonometer. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1930. Implant flag: N. Life-sustain/support flag: N.

Official code: HLC. Product type: Instrument, Measuring, Stereopsis. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1460. Implant flag: N. Life-sustain/support flag: N.

Official code: HLD. Product type: Engine, Trephine, Accessories, Gas-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. Implant flag: N. Life-sustain/support flag: N.

Official code: HLE. Product type: Ruler, Nearpoint (Punctometer). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1790. Implant flag: N. Life-sustain/support flag: N.

Official code: HLF. Product type: Device, Measuring, Lens Radius, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1430. Implant flag: N. Life-sustain/support flag: N.

Official code: HLG. Product type: Pupillometer, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: HLH. Product type: Pupillometer, Manual. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: HLI. Product type: Ophthalmoscope, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: HLJ. Product type: Ophthalmoscope, Battery-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: HLK. Product type: Screen, Tangent, Target, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HLL. Product type: Monitor, Eye Movement. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1510. Implant flag: N. Life-sustain/support flag: N.

Official code: HLM. Product type: Instrument, Measuring, Lens, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1425. Implant flag: N. Life-sustain/support flag: N.

Official code: HLN. Product type: Gauge, Lens, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1420. Implant flag: N. Life-sustain/support flag: N.

Official code: HLO. Product type: Test, Spectacle Dissociation, Battery-Powered (Lancaster). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1910. Implant flag: N. Life-sustain/support flag: N.

Official code: HLP. Product type: Target, Fusion And Stereoscopic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1880. Implant flag: N. Life-sustain/support flag: N.

Official code: HLQ. Product type: Keratoscope, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1350. Implant flag: N. Life-sustain/support flag: N.

Official code: HLR. Product type: Keratoscope, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1350. Implant flag: N. Life-sustain/support flag: N.

Official code: HLS. Product type: Exophthalmometer. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1270. Implant flag: N. Life-sustain/support flag: N.

Official code: HLT. Product type: Preamplifier, Ac-Powered, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: HLW. Product type: Preamplifier, Battery-Powered, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: HLX. Product type: Photostimulator, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: HLZ. Product type: Electrode, Corneal. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1220. Implant flag: N. Life-sustain/support flag: N.

Official code: HMC. Product type: Monitor, Eye Movement, Diagnostic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1510. Implant flag: N. Life-sustain/support flag: N.

Official code: HMD. Product type: Chair, Ophthalmic, Manual. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1140. Implant flag: N. Life-sustain/support flag: N.

Official code: HME. Product type: Chair, Ophthalmic, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1140. Implant flag: N. Life-sustain/support flag: N.

Official code: HMF. Product type: Stand, Instrument, Ac-Powered, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: HMG. Product type: Stand, Instrument, Ophthalmic, Non-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: HMH. Product type: Rack, Skiascopic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1750. Implant flag: N. Life-sustain/support flag: N.

Official code: HMJ. Product type: Screen, Tangent, Projection, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HMK. Product type: Euthyscope, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: HML. Product type: Euthyscope, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: HMM. Product type: Distometer. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1190. Implant flag: N. Life-sustain/support flag: N.

Official code: HMN. Product type: Suture, Nonabsorable, Ophthalmic. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: HMO. Product type: Suture, Absorbable, Ophthalmic. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: HMP. Product type: Pad, Eye. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4440. Implant flag: N. Life-sustain/support flag: N.

Official code: HMQ. Product type: Marker, Sclera. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4570. Implant flag: N. Life-sustain/support flag: N.

Official code: HMR. Product type: Marker, Ocular. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4570. Implant flag: N. Life-sustain/support flag: N.

Official code: HMS. Product type: Drum, Eye Knife Test. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4230. Implant flag: N. Life-sustain/support flag: N.

Official code: HMT. Product type: Drape, Patient, Ophthalmic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: HMW. Product type: Drape, Microscope, Ophthalmic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: HMX. Product type: Cannula, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HMY. Product type: Keratome, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: HMZ. Product type: Trabeculotome. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNA. Product type: Spud, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNB. Product type: Spoon, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNC. Product type: Specula, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HND. Product type: Spatula, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNE. Product type: Snare, Enucleating. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNF. Product type: Scissors, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNG. Product type: Rongeur, Lachrymal Sac. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNH. Product type: Ring, Ophthalmic (Flieringa). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNI. Product type: Retractor, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNJ. Product type: Punch, Corneo-Scleral. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNK. Product type: Probe, Trabeculotomy. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNL. Product type: Probe, Lachrymal. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNM. Product type: Needle, Ophthalmic Suturing. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNN. Product type: Knife, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNO. Product type: Keratome, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: HNP. Product type: Introducer, Sphere. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNQ. Product type: Hook, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNR. Product type: Forceps, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNS. Product type: Expressor. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNT. Product type: Erisophake. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNW. Product type: Dilator, Lachrymal. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNX. Product type: Depressor, Orbital. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNY. Product type: Cystotome. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HNZ. Product type: Curette, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOA. Product type: Compressor, Orbital. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOB. Product type: Clamp, Muscle, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOC. Product type: Clip, Iris Retractor. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOD. Product type: Clamp, Eyelid, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOE. Product type: Caliper, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOF. Product type: Burr, Corneal, Manual. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HOG. Product type: Burr, Corneal, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. Implant flag: N. Life-sustain/support flag: N.

Official code: HOH. Product type: Spectacle, Operating (Loupe), Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4770. Implant flag: N. Life-sustain/support flag: N.

Official code: HOI. Product type: Spectacle, Magnifying. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5840. Implant flag: N. Life-sustain/support flag: N.

Official code: HOJ. Product type: Screen, Tangent, Target. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HOK. Product type: Screen, Tangent, Projection, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HOL. Product type: Screen, Tangent, Felt (Campimeter). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HOM. Product type: Screen, Tangent, Ac-Powered (Campimeter). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HON. Product type: Perimeter, Manual. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1605. Implant flag: N. Life-sustain/support flag: N.

Official code: HOO. Product type: Perimeter, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1605. Implant flag: N. Life-sustain/support flag: N.

Official code: HOP. Product type: Campimeter, Stereo, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: HOQ. Product type: Grid, Amsler. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: HOR. Product type: Simulatan (Including Crossed Cylinder). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1840. Implant flag: N. Life-sustain/support flag: N.

Official code: HOS. Product type: Projector, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1680. Implant flag: N. Life-sustain/support flag: N.

Official code: HOT. Product type: Aid, Vision Image Intensification. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5910. Implant flag: N. Life-sustain/support flag: N.

Official code: HOW. Product type: Drum, Opticokinetic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: HOX. Product type: Chart, Visual Acuity. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1150. Implant flag: N. Life-sustain/support flag: N.

Official code: HOY. Product type: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4750. Implant flag: N. Life-sustain/support flag: N.

Official code: HOZ. Product type: Sponge, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4790. Implant flag: N. Life-sustain/support flag: N.

Official code: HPA. Product type: Frame, Trial, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1415. Implant flag: N. Life-sustain/support flag: N.

Official code: HPB. Product type: Clip, Lens, Trial, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: HPC. Product type: Set, Lens, Trial, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1405. Implant flag: N. Life-sustain/support flag: N.

Official code: HPD. Product type: Lens, Bagolini. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1375. Implant flag: N. Life-sustain/support flag: N.

Official code: HPE. Product type: Aid, Vision, Optical, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5915. Implant flag: N. Life-sustain/support flag: N.

Official code: HPF. Product type: Aid, Vision, Electronic, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: HPG. Product type: Aid, Vision, Electronic, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: HPH. Product type: Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat. Official classification: Class III. Official category: Physical Medicine. Regulation number: 890.5275. PMAs to be filed by 7/13/99 (64 FR 18331 (4/14/99)) Implant flag: N. Life-sustain/support flag: N.

Official code: HPI. Product type: Aid, Vision, Optical, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5915. Implant flag: N. Life-sustain/support flag: N.

Official code: HPJ. Product type: Instrument, Visual Field, Laser. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1360. Implant flag: N. Life-sustain/support flag: N.

Official code: HPK. Product type: Tonograph. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1930. Implant flag: N. Life-sustain/support flag: N.

Official code: HPL. Product type: Device, Fixation, Ac-Powered, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1290. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.) Implant flag: N. Life-sustain/support flag: N.

Official code: HPM. Product type: Locator, Metal, Electronic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: HPN. Product type: Magnet, Permanent. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4445. Implant flag: N. Life-sustain/support flag: N.

Official code: HPO. Product type: Magnet, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4440. Implant flag: N. Life-sustain/support flag: N.

Official code: HPP. Product type: Headlamp, Operating, Battery-Operated. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4335. Implant flag: N. Life-sustain/support flag: N.

Official code: HPQ. Product type: Headlamp, Operating, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4335. Implant flag: N. Life-sustain/support flag: N.

Official code: HPS. Product type: Unit, Cryophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4170. Implant flag: N. Life-sustain/support flag: N.

Official code: HPT. Product type: Perimeter, Automatic, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1605. Implant flag: N. Life-sustain/support flag: N.

Official code: HPW. Product type: Probe And Counter, Isotope, For Phosphorus 32. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1670. Implant flag: N. Life-sustain/support flag: N.

Official code: HPX. Product type: Lens, Contact (Polymethylmethacrylate). Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: HPY. Product type: Unit, Electrolysis, Battery-Powered, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4250. Implant flag: N. Life-sustain/support flag: N.

Official code: HPZ. Product type: Implant, Eye Sphere. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3320. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQA. Product type: Unit, Cryotherapy, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4170. Implant flag: N. Life-sustain/support flag: N.

Official code: HQB. Product type: Photocoagulator And Accessories. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4690. Implant flag: N. Life-sustain/support flag: N.

Official code: HQC. Product type: Unit, Phacofragmentation. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4670. Implant flag: N. Life-sustain/support flag: N.

Official code: HQD. Product type: Lens, Contact (Other Material) - Daily. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5916. Implant flag: N. Life-sustain/support flag: N.

Official code: HQE. Product type: Instrument, Vitreous Aspiration And Cutting, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: HQF. Product type: Laser, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4390. Implant flag: N. Life-sustain/support flag: N.

Official code: HQG. Product type: Lens, Spectacle, Non-Custom (Prescription). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5844. Implant flag: N. Life-sustain/support flag: N.

Official code: HQH. Product type: Eye, Artificial, Non-Custom. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: HQJ. Product type: Implant, Absorbable, (Scleral Buckling Methods). Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQL. Product type: Intraocular Lens. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQM. Product type: Keratoprosthesis, Permanent Implant. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3400. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQN. Product type: Conformer, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3130. Implant flag: N. Life-sustain/support flag: N.

Official code: HQO. Product type: Unit, Cautery, Thermal, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4115. Implant flag: N. Life-sustain/support flag: N.

Official code: HQP. Product type: Unit, Cautery, Thermal, Battery-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4115. Implant flag: N. Life-sustain/support flag: N.

Official code: HQQ. Product type: Apparatus, Cautery, Radiofrequency, Battery-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: HQR. Product type: Apparatus, Cautery, Radiofrequency, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: HQS. Product type: Burr, Corneal, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. Implant flag: N. Life-sustain/support flag: N.

Official code: HQT. Product type: Shell, Scleral. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3800. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQW. Product type: Clip, Tantalum, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3100. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQX. Product type: Implant, Orbital, Extra-Ocular. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3340. Implant flag: Y. Life-sustain/support flag: N.

Official code: HQY. Product type: Sunglasses (Non-Prescription Including Photosensitive). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5850. Implant flag: N. Life-sustain/support flag: N.

Official code: HQZ. Product type: Frame, Spectacle. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5842. Implant flag: N. Life-sustain/support flag: N.

Official code: HRB. Product type: Microscope, Operating, Non-Electric, Ophthalmic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4700. Implant flag: N. Life-sustain/support flag: N.

Official code: HRC. Product type: Sterilizer, Soft-Lens, Thermal, Battery-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5928. Implant flag: N. Life-sustain/support flag: N.

Official code: HRD. Product type: Sterilizer, Soft-Lens, Thermal, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5928. Implant flag: N. Life-sustain/support flag: N.

Official code: HRE. Product type: Cabinet, Instrument, Ac-Powered, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: HRF. Product type: Engine, Trephine, Accessories, Battery-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. Implant flag: N. Life-sustain/support flag: N.

Official code: HRG. Product type: Engine, Trephine, Accessories, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. Implant flag: N. Life-sustain/support flag: N.

Official code: HRH. Product type: Trephine, Manual, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: HRI. Product type: Pupillograph. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1690. Implant flag: N. Life-sustain/support flag: N.

Official code: HRJ. Product type: Table, Instrument, Powered, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4855. Implant flag: N. Life-sustain/support flag: N.

Official code: HRK. Product type: Table, Instrument, Manual, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4855. Implant flag: N. Life-sustain/support flag: N.

Official code: HRL. Product type: Unit, Beta, Radiation, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: HRM. Product type: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4700. Implant flag: N. Life-sustain/support flag: N.

Official code: HRN. Product type: Unit, Cryophthalmic, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4170. Implant flag: N. Life-sustain/support flag: N.

Official code: HRO. Product type: Unit, Electrolysis, Ac-Powered, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4250. Implant flag: N. Life-sustain/support flag: N.

Official code: HRP. Product type: Pen, Marking, Surgical. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4570. Implant flag: N. Life-sustain/support flag: N.

Official code: HRQ. Product type: Hemostat. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HRR. Product type: Scissors, Orthopedic, Surgical. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HRS. Product type: Plate, Fixation, Bone. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: HRT. Product type: Stripper, Surgical. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HRW. Product type: Dynamometer, Nonpowered. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: HRX. Product type: Arthroscope. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1100. Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: HRY. Product type: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3530. Implant flag: Y. Life-sustain/support flag: N.

Official code: HRZ. Product type: Prosthesis, Knee, Hinged (Metal-Metal). Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3480. PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: HSA. Product type: Prosthesis, Knee, Hemi-, Femoral. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3570. Implant flag: Y. Life-sustain/support flag: N.

Official code: HSB. Product type: Rod, Fixation, Intramedullary And Accessories. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3020. Implant flag: Y. Life-sustain/support flag: N.

Official code: HSD. Product type: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3690. Implant flag: Y. Life-sustain/support flag: N.

Official code: HSH. Product type: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented). Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3590. Implant flag: Y. Life-sustain/support flag: N.

Official code: HSN. Product type: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3110. Implant flag: Y. Life-sustain/support flag: N.

Official code: HSO. Product type: Saw. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HSP. Product type: Splint, Traction. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: HSQ. Product type: Belt, Pelvic, Traction. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: HSR. Product type: Unit, Traction, Hip, Non-Powered, Non-Penetrating. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: HSS. Product type: Halter, Head, Traction. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: HST. Product type: Apparatus, Traction, Non-Powered. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5850. Implant flag: N. Life-sustain/support flag: N.

Official code: HSX. Product type: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3520. Implant flag: Y. Life-sustain/support flag: N.

Official code: HSZ. Product type: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: HTC. Product type: Pliers, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HTD. Product type: Forceps. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HTE. Product type: Elevator. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HTF. Product type: Curette. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HTG. Product type: Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3580. Implant flag: Y. Life-sustain/support flag: N.

Official code: HTH. Product type: Protractor. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4600. Implant flag: N. Life-sustain/support flag: N.

Official code: HTJ. Product type: Gauge, Depth. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: HTM. Product type: Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: HTN. Product type: Washer, Bolt Nut. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: HTO. Product type: Reamer. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTP. Product type: File. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTQ. Product type: Broach. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTR. Product type: Rasp. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HTS. Product type: Knife, Orthopedic. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTT. Product type: Burr, Orthopedic. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTW. Product type: Bit, Drill. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTX. Product type: Rongeur. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HTY. Product type: Pin, Fixation, Smooth. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: HTZ. Product type: Instrument, Cutting, Orthopedic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HWA. Product type: Impactor. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWB. Product type: Extractor. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWC. Product type: Screw, Fixation, Bone. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: HWD. Product type: Starter, Bone Screw. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWE. Product type: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: HWF. Product type: Prosthesis, Ligament. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: HWI. Product type: Corkscrew. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWJ. Product type: Awl. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWK. Product type: Trephine. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWL. Product type: Set, Hollow Mill. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWM. Product type: Osteotome. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HWN. Product type: Instrument, Compression. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWO. Product type: Skid, Bone. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWP. Product type: Punch, Femoral Neck. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWQ. Product type: Passer. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWR. Product type: Driver, Prosthesis. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWT. Product type: Template. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HWW. Product type: Countersink. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HWX. Product type: Tap, Bone. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXA. Product type: Prosthesis, Tendon, Passive. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3025. Implant flag: Y. Life-sustain/support flag: N.

Official code: HXB. Product type: Probe. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXC. Product type: Wrench. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXD. Product type: Clamp. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HXE. Product type: Fork. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXG. Product type: Tamp. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXI. Product type: Passer, Wire, Orthopedic. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXJ. Product type: Staple Driver. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXK. Product type: Holder, Needle; Orthopedic. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXL. Product type: Mallet. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HXN. Product type: Applier, Cerclage. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXO. Product type: Pusher, Socket. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXP. Product type: Instrument, Bending Or Contouring. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXQ. Product type: Crimper, Pin. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXR. Product type: Spatula, Orthopedic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HXS. Product type: Twister, Wire. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXT. Product type: Tape, Orthopedic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HXW. Product type: Bender. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXX. Product type: Screwdriver. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXY. Product type: Brace, Drill. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HXZ. Product type: Cutter, Wire. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: HYA. Product type: Forceps, Wire Holding. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: HYB. Product type: Eosin Y. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYC. Product type: Fast Green. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYD. Product type: Fast Red Salt B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYE. Product type: Solution, Fontanna Silver. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYF. Product type: Giemsa Stain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYG. Product type: Glenner'S Stain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYH. Product type: Gold Chloride. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYI. Product type: Iodine, Grams. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYJ. Product type: Hematoxylin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYK. Product type: Hematoxylin Harris'S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYL. Product type: Hematoxylin Mayer'S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYO. Product type: Hematoxylin Weigert'S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYQ. Product type: Iron Chloride-Weigert. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYR. Product type: Leuco-Patent Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYS. Product type: Light Green. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYT. Product type: Luxol Fast Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYW. Product type: Stain, Trichrome, Mallory'S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYY. Product type: Metanil Yellow. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HYZ. Product type: Methenamine Silver. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZA. Product type: Methyl Green. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZC. Product type: Mucicarmine. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZD. Product type: Muller'S Colloidal Iron. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZE. Product type: Nile Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZF. Product type: Nuclear Fast Red. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZG. Product type: Oil Red O. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZH. Product type: Orange G. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZI. Product type: Acid, Osmic. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: HZJ. Product type: Stain, Papanicolau. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZL. Product type: Phloxine B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZM. Product type: Hematoxylin, Acid, Phosphotungstic. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZN. Product type: Picro Methyl Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZO. Product type: Stain, Ponceau. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZP. Product type: Pyronin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZQ. Product type: Red-Violet Lb. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZR. Product type: Resorcin Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZS. Product type: Safranin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZT. Product type: Reagent, Schiff. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZX. Product type: Silver Nitrate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZY. Product type: Sirius Red. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: HZZ. Product type: Sudan Black B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAA. Product type: Titan Yellow. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAB. Product type: Toluidine Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAC. Product type: Van Gieson'S Stain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAD. Product type: Van Gieson'S Picro-Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAE. Product type: Hematoxylin, Iron, Weigert'S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAF. Product type: Wright'S Stain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IAL. Product type: Iodine (Tincture). Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IAM. Product type: Solution, Lugol'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IAT. Product type: Syrup, Gum, Apathy'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IAW. Product type: Collodion. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IAY. Product type: Colchicine. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IAZ. Product type: Heparin. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBA. Product type: Streptolysin O. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBB. Product type: Phytohemaglutinin M. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IBC. Product type: Diastase. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBD. Product type: Hyaluronidase. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBE. Product type: Neuramininase (Sialidase). Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBF. Product type: Papain. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBG. Product type: Trypsin. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: IBJ. Product type: Light, Microscope. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: IBK. Product type: Microscope, Fluorescence/U.V.. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: IBL. Product type: Microscope, Inverted Stage, Tissue Culture. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: IBM. Product type: Microscope, Phase Contrast. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: ICC. Product type: Eosin B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICD. Product type: Darrow Red. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICF. Product type: Crystal Violet For Histology. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICG. Product type: Cresyl Violet Acetate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICH. Product type: Congo Red. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICI. Product type: Hematoxylin, Chrome Alum. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICJ. Product type: Carbol Night Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICL. Product type: Carbol Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICM. Product type: Brilliant Yellow. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICN. Product type: Biebrich Scarlet. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICO. Product type: Best'S Carmine. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICQ. Product type: Azure A. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICR. Product type: Azocarmine B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICS. Product type: Azocarmine G. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICT. Product type: Azan Counterstain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICX. Product type: Aniline. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICY. Product type: Acid, Aniline, Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ICZ. Product type: Ammoniacal Silver Hydroxide Silver Nitrate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDA. Product type: Alcian Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDB. Product type: Aldehyde Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDC. Product type: Acridine Orange. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDD. Product type: Alizarin Red. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDE. Product type: Acid, Hematein. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDF. Product type: Acid, Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IDL. Product type: Microtome, Accessories. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDM. Product type: Microtome, Ultra. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDN. Product type: Microtome, Freezing Attachment. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDO. Product type: Microtome, Rotary. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDP. Product type: Microtome, Cryostat. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDQ. Product type: Infiltrator. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDR. Product type: Ovens, Paraffin. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDS. Product type: Melting Pot, Paraffin. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDT. Product type: Apparatus, Melting Point, Paraffin. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDW. Product type: Dispensers, Paraffin. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDX. Product type: Sieves, Tissue. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDY. Product type: Bath, Flotation, Tissue. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IDZ. Product type: Cassettes, Tissue. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IEG. Product type: Table, Slide Warming. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IEH. Product type: Lamps, Slide Warming. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IEO. Product type: Processor, Tissue, Automated. Official classification: Class I. Official category: Pathology. Regulation number: 864.3875. Implant flag: N. Life-sustain/support flag: N.

Official code: IER. Product type: Polyethylene Glycol (Carbowax). Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IEX. Product type: Gelatin. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IEZ. Product type: Celloidin. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFB. Product type: Cytocentrifuge. Official classification: Class I. Official category: Pathology. Regulation number: 864.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: IFF. Product type: Solution, Decalcifier, Electrolytic. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFH. Product type: Solution, Zenker'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFI. Product type: Sprays, Synthetic, Smear. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFJ. Product type: Fixative, Richardson Glycol. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFL. Product type: Polyethylene Glycol Preservative. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFN. Product type: Solution, Orth'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFO. Product type: Solution, Newcomer'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFP. Product type: Formalin, Neutral Buffered. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFQ. Product type: Formulations, Mercuric Chloride For Tissue. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFS. Product type: Solution, Helly. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFT. Product type: Glutaraldehyde. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFY. Product type: Gelatin-Formalin. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IFZ. Product type: Gelatin For Specimen Adhesion. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGB. Product type: Solution, Formalin-Sodium Acetate. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGC. Product type: Formalin-Saline. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGD. Product type: Solution, Formol Calcium. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGE. Product type: Solution, Formalin Ammonium Bromide. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGF. Product type: Solution, Formalin-Alcohol-Acetic Acid. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGG. Product type: Formaldehyde (Formalin, Formol). Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGK. Product type: Solution, Clarke'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGM. Product type: Solution, Carnoy'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IGN. Product type: Fluid, Bouin'S. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IHJ. Product type: Blender, Sputum. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: IJZ. Product type: Oil, Clearing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: IKD. Product type: Cable, Electrode. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: IKE. Product type: Transducer, Miniature Pressure. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.1615. Implant flag: N. Life-sustain/support flag: N.

Official code: IKK. Product type: System, Isokinetic Testing And Evaluation. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1925. Implant flag: N. Life-sustain/support flag: N.

Official code: IKN. Product type: Electromyograph, Diagnostic. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1375. Implant flag: N. Life-sustain/support flag: N.

Official code: IKO. Product type: Hammer, Reflex, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1450. Implant flag: N. Life-sustain/support flag: N.

Official code: IKP. Product type: Chronaximeter. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1225. Implant flag: N. Life-sustain/support flag: N.

Official code: IKT. Product type: Electrode, Needle, Diagnostic Electromyograph. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: IKW. Product type: Utensil, Homemaking. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IKX. Product type: Aid, Transfer. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IKY. Product type: Mattress, Flotation Therapy, Non-Powered. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: IKZ. Product type: Bed, Patient Rotation, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5225. Implant flag: N. Life-sustain/support flag: N.

Official code: ILC. Product type: Utensil, Eating. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: ILD. Product type: Adaptor, Dressing. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: ILE. Product type: Sling, Arm, Overhead Supported. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ILG. Product type: Stocking, Elastic. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ILH. Product type: Splint, Hand, And Components. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ILI. Product type: Sling, Arm. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: ILJ. Product type: Bath, Hydro-Massage. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: ILK. Product type: Transport, Patient, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5150. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs. Implant flag: N. Life-sustain/support flag: N.

Official code: ILM. Product type: Bath, Sitz, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: ILO. Product type: Pack, Hot Or Cold, Water Circulating. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5720. Implant flag: N. Life-sustain/support flag: N.

Official code: ILP. Product type: System, Communication, Non-Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: ILQ. Product type: System, Communication, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3710. Implant flag: N. Life-sustain/support flag: N.

Official code: ILS. Product type: Adaptor, Hygiene. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: ILT. Product type: Adaptor, Recreational. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: ILW. Product type: Adaptor, Grooming. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: ILX. Product type: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5290. Implant flag: N. Life-sustain/support flag: N.

Official code: ILY. Product type: Lamp, Infrared, Therapeutic Heating. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: ILZ. Product type: Accessories, Traction. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: IMA. Product type: Pack, Heat, Moist. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5730. Implant flag: N. Life-sustain/support flag: N.

Official code: IMB. Product type: Cabinet, Moist Steam. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: IMC. Product type: Bath, Paraffin. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5110. Implant flag: N. Life-sustain/support flag: N.

Official code: IMD. Product type: Pack, Hot Or Cold, Disposable. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5710. Implant flag: N. Life-sustain/support flag: N.

Official code: IME. Product type: Pack, Hot Or Cold, Reusable. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: IMF. Product type: Unit, Chilling. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5940. Implant flag: N. Life-sustain/support flag: N.

Official code: IMG. Product type: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5860. Implant flag: N. Life-sustain/support flag: N.

Official code: IMI. Product type: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: IMJ. Product type: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5290. Implant flag: N. Life-sustain/support flag: N.

Official code: IMK. Product type: Wheelchair, Stair Climbing. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3890. A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. Implant flag: N. Life-sustain/support flag: N.

Official code: IML. Product type: Armrest, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMM. Product type: Footrest, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMN. Product type: Climber, Curb, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMO. Product type: Handrim, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMP. Product type: Cushion, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMQ. Product type: Attachment, Narrowing, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMR. Product type: Device, Anti-Tip, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMS. Product type: Support, Head And Trunk, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: IMW. Product type: Brake, Extension, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IMX. Product type: Board, Lap, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: IMY. Product type: Armboard, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: IMZ. Product type: Holder, Crutch And Cane, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: INA. Product type: Hill Holder, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: INB. Product type: Attachment, Commode, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: INC. Product type: Cuff, Pusher, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: INE. Product type: Sling, Overhead Suspension, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: INF. Product type: Scale, Platform, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3940. Implant flag: N. Life-sustain/support flag: N.

Official code: ING. Product type: Elevator, Wheelchair, Portable. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3930. A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs). Implant flag: N. Life-sustain/support flag: N.

Official code: INI. Product type: Vehicle, Motorized 3-Wheeled. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: INK. Product type: Stretcher, Wheeled, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3690. Implant flag: N. Life-sustain/support flag: N.

Official code: INM. Product type: Chair, With Casters. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: INN. Product type: Chair, Adjustable, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: INO. Product type: Chair, Positioning, Electric. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: INP. Product type: Tips And Pads, Cane, Crutch And Walker. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3790. Implant flag: N. Life-sustain/support flag: N.

Official code: INQ. Product type: Table, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3760. Implant flag: N. Life-sustain/support flag: N.

Official code: INT. Product type: Plinth. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: INW. Product type: Table, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: INX. Product type: Bed, Air Fluidized. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: INY. Product type: Bed, Patient Rotation, Manual. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5180. Implant flag: N. Life-sustain/support flag: N.

Official code: IOA. Product type: Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5275. Implant flag: N. Life-sustain/support flag: N.

Official code: IOB. Product type: Lamp, Infrared, Non Heating. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: IOD. Product type: Components, Exercise. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: IOE. Product type: Bars, Parallel, Exercise. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5370. Implant flag: N. Life-sustain/support flag: N.

Official code: IOG. Product type: Treadmill, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5370. Implant flag: N. Life-sustain/support flag: N.

Official code: IOL. Product type: Treadmill, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5380. Implant flag: N. Life-sustain/support flag: N.

Official code: ION. Product type: Exerciser, Non-Measuring. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5370. Implant flag: N. Life-sustain/support flag: N.

Official code: IOQ. Product type: Bed, Flotation Therapy, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5170. Implant flag: N. Life-sustain/support flag: N.

Official code: IOR. Product type: Wheelchair, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3850. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility. Implant flag: N. Life-sustain/support flag: N.

Official code: IOY. Product type: Support, Arm. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: IOZ. Product type: Splint, Abduction, Congenital Hip Dislocation. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3665. Implant flag: N. Life-sustain/support flag: N.

Official code: IPF. Product type: Stimulator, Muscle, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5850. Implant flag: N. Life-sustain/support flag: N.

Official code: IPG. Product type: Shoe, Cast. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: IPL. Product type: Wheelchair, Standup. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: IPM. Product type: Cover, Limb. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: IPO. Product type: Orthosis, Pneumatic Structure, Rigid. Official classification: Class III. Official category: Physical Medicine. Regulation number: 890.3610. Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: IPR. Product type: Crutch. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: IPS. Product type: Cane. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3075. Implant flag: N. Life-sustain/support flag: N.

Official code: IPT. Product type: Orthosis, Thoracic. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IPW. Product type: Orthosis, Sacroiliac, Soft. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IPX. Product type: Orthosis, Rib Fracture, Soft. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IPY. Product type: Orthosis, Lumbo-Sacral. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IQA. Product type: System, Environmental Control, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3725. Implant flag: N. Life-sustain/support flag: N.

Official code: IQB. Product type: Belt, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: IQC. Product type: Wheelchair, Special Grade. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: IQE. Product type: Orthosis, Lumbar. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IQF. Product type: Orthosis, Cervical-Thoracic, Rigid. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IQG. Product type: Adaptor, Holder, Syringe. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IQI. Product type: Orthosis, Limb Brace. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: IQJ. Product type: Splint, Clavicle. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IQK. Product type: Orthosis, Cervical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: IQM. Product type: Splint, Temporary Training. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: IQO. Product type: Device, Prosthesis Alignment. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: IQP. Product type: Rotator, Transverse. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: IQQ. Product type: Joint, Shoulder, External Limb Component. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IQW. Product type: Hook, External Limb Component, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IQX. Product type: Hook, External Limb Component, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IQZ. Product type: Hand, External Limb Component, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IRA. Product type: Hand, External Limb Component, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IRD. Product type: Joint, Elbow, External Limb Component, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IRE. Product type: Joint, Elbow, External Limb Component, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: IRN. Product type: Device, Warning, Overload, External Limb, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5575. Implant flag: N. Life-sustain/support flag: N.

Official code: IRO. Product type: Vibrator, Therapeutic. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5975. Implant flag: N. Life-sustain/support flag: N.

Official code: IRP. Product type: Massager, Powered Inflatable Tube. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5650. Implant flag: N. Life-sustain/support flag: N.

Official code: IRQ. Product type: Unit, Heating, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5950. Implant flag: N. Life-sustain/support flag: N.

Official code: IRR. Product type: Bars, Parallel, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5380. Implant flag: N. Life-sustain/support flag: N.

Official code: IRS. Product type: Head Halter, Traction. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: IRT. Product type: Pad, Heating, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5740. Implant flag: N. Life-sustain/support flag: N.

Official code: ISA. Product type: Massager, Therapeutic, Electric. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: ISB. Product type: Stimulator, Muscle, Diagnostic. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: ISD. Product type: Exerciser, Measuring. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5360. Implant flag: N. Life-sustain/support flag: N.

Official code: ISH. Product type: Component, External, Limb, Ankle/Foot. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ISL. Product type: Joint, Hip, External Limb Component. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ISM. Product type: Pylon, Post Surgical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: ISN. Product type: Cable. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ISP. Product type: Valve, Prosthesis. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ISR. Product type: Band Or Belt, Pelvic Support. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: ISS. Product type: Prosthesis, Thigh Socket, External Component. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ISW. Product type: Assembly, Knee/Shank/Ankle/Foot, External. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: ISY. Product type: Joint, Knee, External Limb Component. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ISZ. Product type: Unit, Wrist, External Limb Component, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: ITC. Product type: Stirrup, External Brace Component. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: ITG. Product type: Bandage, Cast. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: ITH. Product type: Equipment, Traction, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: ITI. Product type: Wheelchair, Powered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3860. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK). Implant flag: N. Life-sustain/support flag: N.

Official code: ITJ. Product type: Walker, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3825. Implant flag: N. Life-sustain/support flag: N.

Official code: ITM. Product type: Cage, Knee. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ITN. Product type: Splint, Denis Brown. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3675. Implant flag: N. Life-sustain/support flag: N.

Official code: ITO. Product type: Twister, Brace Setting. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: ITQ. Product type: Joint, Knee, External Brace. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ITS. Product type: Joint, Hip, External Brace. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ITW. Product type: Joint, Ankle, External Brace. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: ITX. Product type: Transducer, Ultrasonic, Diagnostic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: ITY. Product type: Assembly, Tube Housing, X-Ray, Diagnostic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1760. Implant flag: N. Life-sustain/support flag: N.

Official code: ITZ. Product type: Assembly, Tube Housing, X-Ray, Therapeutic. Official classification: Class II. Official category: Radiology. Regulation number: 892.5930. Implant flag: N. Life-sustain/support flag: N.

Official code: IWA. Product type: Source, Wire, Iridium, Radioactive. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. Implant flag: N. Life-sustain/support flag: N.

Official code: IWB. Product type: System, Radiation Therapy, Radionuclide. Official classification: Class II. Official category: Radiology. Regulation number: 892.5750. Implant flag: N. Life-sustain/support flag: N.

Official code: IWD. Product type: Device, Beam Limiting, Teletherapy, Radionuclide. Official classification: Class II. Official category: Radiology. Regulation number: 892.5750. Implant flag: N. Life-sustain/support flag: N.

Official code: IWE. Product type: Monitor, Patient Position, Light-Beam. Official classification: Class I. Official category: Radiology. Regulation number: 892.5780. Implant flag: N. Life-sustain/support flag: N.

Official code: IWF. Product type: Needle, Isotope, Gold, Titanium, Platinum. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. Implant flag: N. Life-sustain/support flag: N.

Official code: IWG. Product type: Seed, Isotope, Gold, Titanium, Platinum. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. Implant flag: Y. Life-sustain/support flag: N.

Official code: IWH. Product type: Source, Teletherapy, Radionuclide. Official classification: Class I. Official category: Radiology. Regulation number: 892.5740. Implant flag: N. Life-sustain/support flag: N.

Official code: IWI. Product type: Source, Isotope, Sealed, Gold, Titanium, Platinum. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. Implant flag: N. Life-sustain/support flag: N.

Official code: IWJ. Product type: System, Applicator, Radionuclide, Manual. Official classification: Class I. Official category: Radiology. Regulation number: 892.5650. Implant flag: N. Life-sustain/support flag: N.

Official code: IWK. Product type: Cyclotron, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IWL. Product type: System, Radiation Therapy, Neutron, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: IWM. Product type: Synchrotron, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IWN. Product type: Cassette, Measurement, Ardran-Crooks. Official classification: Class I. Official category: Radiology. Regulation number: 892.1940. Implant flag: N. Life-sustain/support flag: N.

Official code: IWO. Product type: Apron, Protective. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWP. Product type: Radiographic Protective Glove. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. - Implant flag: N. Life-sustain/support flag: N.

Official code: IWQ. Product type: Curtain, Protective, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWR. Product type: Holder, Syringe, Lead. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWS. Product type: Shield, Eye, Radiological. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWT. Product type: Shield, Gonadal. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWW. Product type: Shield, Vial. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWX. Product type: Barrier, Control Panel, X-Ray, Movable. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: IWY. Product type: Holder, Head, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1920. Implant flag: N. Life-sustain/support flag: N.

Official code: IWZ. Product type: Film, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1840. Implant flag: N. Life-sustain/support flag: N.

Official code: IXA. Product type: Cassette, Radiographic Film. Official classification: Class II. Official category: Radiology. Regulation number: 892.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: IXC. Product type: Illuminator, Radiographic-Film. Official classification: Class I. Official category: Radiology. Regulation number: 892.1890. Implant flag: N. Life-sustain/support flag: N.

Official code: IXD. Product type: Source, Calibration, Sealed, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1400. Implant flag: N. Life-sustain/support flag: N.

Official code: IXF. Product type: Test-Pattern, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1940. Implant flag: N. Life-sustain/support flag: N.

Official code: IXG. Product type: Phantom, Anthropomorphic, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1950. Implant flag: N. Life-sustain/support flag: N.

Official code: IXH. Product type: Camera, Focal Spot, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1940. Implant flag: N. Life-sustain/support flag: N.

Official code: IXI. Product type: Block, Beam-Shaping, Radiation Therapy. Official classification: Class II. Official category: Radiology. Regulation number: 892.5710. Implant flag: N. Life-sustain/support flag: N.

Official code: IXJ. Product type: Grid, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1910. Implant flag: N. Life-sustain/support flag: N.

Official code: IXK. Product type: System, Imaging, X-Ray, Electrostatic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: IXL. Product type: Device, Spot-Film. Official classification: Class II. Official category: Radiology. Regulation number: 892.1670. Implant flag: N. Life-sustain/support flag: N.

Official code: IXO. Product type: Synchronizer, Ecg / Respirator, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1970. Implant flag: N. Life-sustain/support flag: N.

Official code: IXQ. Product type: Table, Radiographic, Stationary Top. Official classification: Class II. Official category: Radiology. Regulation number: 892.1980. Implant flag: N. Life-sustain/support flag: N.

Official code: IXR. Product type: Table, Radiographic, Tilting. Official classification: Class II. Official category: Radiology. Regulation number: 892.1980. Implant flag: N. Life-sustain/support flag: N.

Official code: IXW. Product type: Processor, Radiographic-Film, Automatic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: IXX. Product type: Processor, Cine Film. Official classification: Class II. Official category: Radiology. Regulation number: 892.1900. Implant flag: N. Life-sustain/support flag: N.

Official code: IXY. Product type: Holder, Radiographic Cassette, Wall-Mounted. Official classification: Class I. Official category: Radiology. Regulation number: 892.1880. Implant flag: N. Life-sustain/support flag: N.

Official code: IYB. Product type: Tube Mount, X-Ray, Diagnostic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: IYC. Product type: Generator, Orthovoltage, Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYD. Product type: Generator, Low Voltage, Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYE. Product type: Accelerator, Linear, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IYG. Product type: Betatron, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: IYH. Product type: Generator, Dermatological (Grenz Ray), Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYI. Product type: Collimator, Orthovoltage, Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYJ. Product type: Collimator, Low Voltage, Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYK. Product type: Collimator, High Voltage, Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYL. Product type: Collimator, Dermatological, Therapeutic X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: IYM. Product type: System, Telethermographic, Infrared. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2980. Implant flag: N. Life-sustain/support flag: N.

Official code: IYN. Product type: System, Imaging, Pulsed Doppler, Ultrasonic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1550. Implant flag: N. Life-sustain/support flag: N.

Official code: IYO. Product type: System, Imaging, Pulsed Echo, Ultrasonic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1560. Implant flag: N. Life-sustain/support flag: N.

Official code: IYP. Product type: Phantom, Anthropomorphic, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1370. Implant flag: N. Life-sustain/support flag: N.

Official code: IYQ. Product type: Phantom, Flood Source, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1380. Implant flag: N. Life-sustain/support flag: N.

Official code: IYT. Product type: System, Rebreathing, Radionuclide. Official classification: Class II. Official category: Radiology. Regulation number: 892.1390. Implant flag: N. Life-sustain/support flag: N.

Official code: IYW. Product type: Scanner, Rectilinear, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: IYX. Product type: Camera, Scintillation (Gamma). Official classification: Class I. Official category: Radiology. Regulation number: 892.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: IYY. Product type: Synchronizer, Electrocardiograph, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: IYZ. Product type: Bed, Scanning, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1350. Implant flag: N. Life-sustain/support flag: N.

Official code: IZC. Product type: Camera, Positron. Official classification: Class I. Official category: Radiology. Regulation number: 892.1110. Implant flag: N. Life-sustain/support flag: N.

Official code: IZD. Product type: Probe, Uptake, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1320. Implant flag: N. Life-sustain/support flag: N.

Official code: IZF. Product type: System, X-Ray, Tomographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1740. Implant flag: N. Life-sustain/support flag: N.

Official code: IZG. Product type: System, X-Ray, Photofluorographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: IZH. Product type: System, X-Ray, Mammographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1710. Implant flag: N. Life-sustain/support flag: N.

Official code: IZI. Product type: System, X-Ray, Angiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: IZJ. Product type: Camera, X-Ray, Fluorographic, Cine Or Spot. Official classification: Class II. Official category: Radiology. Regulation number: 892.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: IZL. Product type: System, X-Ray, Mobile. Official classification: Class II. Official category: Radiology. Regulation number: 892.1720. Implant flag: N. Life-sustain/support flag: N.

Official code: IZO. Product type: Generator, High-Voltage, X-Ray, Diagnostic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: IZP. Product type: Programmer, Changer, Film/Cassette, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1870. Implant flag: N. Life-sustain/support flag: N.

Official code: IZQ. Product type: Injector, Contrast Medium, Automatic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: IZS. Product type: Aperture, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: IZT. Product type: Cone, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: IZW. Product type: Collimator, Automatic, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: IZX. Product type: Collimator, Manual, Radiographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: IZZ. Product type: Table, Radiographic, Non-Tilting, Powered. Official classification: Class II. Official category: Radiology. Regulation number: 892.1980. Implant flag: N. Life-sustain/support flag: N.

Official code: JAA. Product type: System, X-Ray, Fluoroscopic, Image-Intensified. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: JAB. Product type: System, X-Ray, Fluoroscopic, Non-Image-Intensified. Official classification: Class II. Official category: Radiology. Regulation number: 892.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JAC. Product type: System, X-Ray, Film Marking, Radiographic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: JAD. Product type: System, Therapeutic, X-Ray. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: JAE. Product type: Microtron, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: JAF. Product type: Monitor, Ultrasonic, Nonfetal. Official classification: Class II. Official category: Radiology. Regulation number: 892.1540. Implant flag: N. Life-sustain/support flag: N.

Official code: JAG. Product type: Illuminator, Radiographic-Film, Explosion-Proof. Official classification: Class I. Official category: Radiology. Regulation number: 892.1890. Implant flag: N. Life-sustain/support flag: N.

Official code: JAI. Product type: Couch, Radiation Therapy, Powered. Official classification: Class II. Official category: Radiology. Regulation number: 892.5770. Implant flag: N. Life-sustain/support flag: N.

Official code: JAK. Product type: System, X-Ray, Tomography, Computed. Official classification: Class II. Official category: Radiology. Regulation number: 892.1750. Implant flag: N. Life-sustain/support flag: N.

Official code: JAM. Product type: Scanner, Whole Body, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: JAN. Product type: Counter, Whole Body, Nuclear. Official classification: Class I. Official category: Radiology. Regulation number: 892.1130. Implant flag: N. Life-sustain/support flag: N.

Official code: JAO. Product type: Scanner, Fluorescent. Official classification: Class II. Official category: Radiology. Regulation number: 892.1220. Implant flag: N. Life-sustain/support flag: N.

Official code: JAQ. Product type: System, Applicator, Radionuclide, Remote-Controlled. Official classification: Class II. Official category: Radiology. Regulation number: 892.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: JAR. Product type: Phantom, Test-Pattern, Radionuclide. Official classification: Class I. Official category: Radiology. Regulation number: 892.1420. Implant flag: N. Life-sustain/support flag: N.

Official code: JAX. Product type: Pneumotachometer. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2550. Implant flag: N. Life-sustain/support flag: N.

Official code: JAY. Product type: Support, Breathing Tube. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5280. Implant flag: N. Life-sustain/support flag: N.

Official code: JAZ. Product type: Prosthesis, Facial, Mandibular Implant. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3695. Implant flag: Y. Life-sustain/support flag: N.

Official code: JBB. Product type: Solubility, Hemoglobin, Abnormal. Official classification: Class II. Official category: Hematology. Regulation number: 864.7825. Implant flag: N. Life-sustain/support flag: N.

Official code: JBD. Product type: System, Analysis, Electrophoretic Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7440. Implant flag: N. Life-sustain/support flag: N.

Official code: JBE. Product type: Cell Enzymes (Erythrocytic And Leukocytic). Official classification: Class II. Official category: Hematology. Regulation number: 864.7100. Implant flag: N. Life-sustain/support flag: N.

Official code: JBF. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBG. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBH. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBI. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBJ. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBK. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBL. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBM. Product type: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JBN. Product type: Fibrin Monomer Paracoagulation. Official classification: Class II. Official category: Hematology. Regulation number: 864.7300. Implant flag: N. Life-sustain/support flag: N.

Official code: JBO. Product type: Test, Euglobulin Lysis. Official classification: Class II. Official category: Hematology. Regulation number: 864.7275. Implant flag: N. Life-sustain/support flag: N.

Official code: JBP. Product type: Activated Whole Blood Clotting Time. Official classification: Class II. Official category: Hematology. Regulation number: 864.7140. Implant flag: N. Life-sustain/support flag: N.

Official code: JBQ. Product type: Antithrombin Iii Quantitation. Official classification: Class II. Official category: Hematology. Regulation number: 864.7060. Implant flag: N. Life-sustain/support flag: N.

Official code: JBR. Product type: Test, Heparin Neutralization. Official classification: Class II. Official category: Hematology. Regulation number: 864.7525. Implant flag: N. Life-sustain/support flag: N.

Official code: JBS. Product type: Timer, General Laboratory. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JBT. Product type: Timer, Coagulation. Official classification: Class II. Official category: Hematology. Regulation number: 864.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: JBW. Product type: Red-Cell Indices, Measured. Official classification: Class II. Official category: Hematology. Regulation number: 864.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: JBX. Product type: Aggregrometer, Platelet. Official classification: Class II. Official category: Hematology. Regulation number: 864.6675. Implant flag: N. Life-sustain/support flag: N.

Official code: JBY. Product type: Aggregometer, Platelet, Photo-Optical Scanning. Official classification: Class II. Official category: Hematology. Regulation number: 864.6675. Implant flag: N. Life-sustain/support flag: N.

Official code: JBZ. Product type: Study, Platelet Adhesive. Official classification: Class II. Official category: Hematology. Regulation number: 864.6650. Implant flag: N. Life-sustain/support flag: N.

Official code: JCA. Product type: Device, Bleeding Time. Official classification: Class II. Official category: Hematology. Regulation number: 864.6100. Implant flag: N. Life-sustain/support flag: N.

Official code: JCB. Product type: Detergent. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: JCC. Product type: Ph Buffer. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: JCE. Product type: Solution, Isotonic. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: JCF. Product type: Lymphocyte Separation Medium. Official classification: Class I. Official category: Hematology. Regulation number: 864.8500. Implant flag: N. Life-sustain/support flag: N.

Official code: JCG. Product type: Fluid, Diluting, Manual Cell. Official classification: Class I. Official category: Hematology. Regulation number: 864.8200. Implant flag: N. Life-sustain/support flag: N.

Official code: JCH. Product type: Esterase. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: JCI. Product type: Acid Phosphatase, Cytochemical. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: JCJ. Product type: Alkaline Phosphatase. Official classification: Class I. Official category: Hematology. Regulation number: 864.7660. Implant flag: N. Life-sustain/support flag: N.

Official code: JCM. Product type: Control, Hemoglobin, Abnormal. Official classification: Class II. Official category: Hematology. Regulation number: 864.7415. Implant flag: N. Life-sustain/support flag: N.

Official code: JCN. Product type: Control, Cell Counter, Normal And Abnormal. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: JCO. Product type: Bothrops Atrox Reagent. Official classification: Class II. Official category: Hematology. Regulation number: 864.8100. Implant flag: N. Life-sustain/support flag: N.

Official code: JCQ. Product type: Prosthesis, Esophagus. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3610. Implant flag: Y. Life-sustain/support flag: N.

Official code: JCT. Product type: Prosthesis, Tracheal, Expandable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3720. Implant flag: Y. Life-sustain/support flag: Y.

Official code: JCW. Product type: Prosthesis, Penis, Inflatable. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.3350. PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00)) Implant flag: Y. Life-sustain/support flag: N.

Official code: JCX. Product type: Apparatus, Suction, Ward Use, Portable, Ac-Powered. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4780. Implant flag: N. Life-sustain/support flag: N.

Official code: JCY. Product type: Catheter, Infusion. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: JDB. Product type: Prosthesis, Elbow, Semi-Constrained, Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3160. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDC. Product type: Prosthesis, Elbow, Constrained, Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3150. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDD. Product type: Prosthesis, Upper Femoral. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3360. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDG. Product type: Prosthesis, Hip, Femoral Component, Cemented, Metal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3360. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDH. Product type: Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3380. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDI. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3350. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDJ. Product type: Mesh, Surgical, Acetabular, Hip, Prosthesis. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDK. Product type: Prosthesis, Hip, Cement Restrictor. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDL. Product type: Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3320. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDN. Product type: Implant, Fixation Device, Spinal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDO. Product type: Device, Fixation, Proximal Femoral, Implant. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDP. Product type: Condylar Plate Fixation Implant. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDQ. Product type: Cerclage, Fixation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3010. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDR. Product type: Staple, Fixation, Bone. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDS. Product type: Nail, Fixation, Bone. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDT. Product type: Cap, Bone. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.3000. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDW. Product type: Pin, Fixation, Threaded. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: JDX. Product type: Instrument, Surgical, Sonic And Accessory/Attachment. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: JDY. Product type: Evacuator, Vapor, Cement Monomer. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4220. Implant flag: N. Life-sustain/support flag: N.

Official code: JDZ. Product type: Mixer, Cement, For Clinical Use. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4210. Implant flag: N. Life-sustain/support flag: N.

Official code: JEA. Product type: Table, Surgical With Orthopedic Accessories, Ac-Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4960. Implant flag: N. Life-sustain/support flag: N.

Official code: JEB. Product type: Table, Surgical With Orthopedic Accessories, Manual. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: JEC. Product type: Component, Traction, Invasive. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: JED. Product type: Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling. Official classification: Class III. Official category: Anesthesiology. Regulation number: 868.1120. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. Implant flag: N. Life-sustain/support flag: N.

Official code: JEF. Product type: Analyzer, Gas, Neon, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1670. Implant flag: N. Life-sustain/support flag: N.

Official code: JEG. Product type: Analyzer, Gas, Argon, Gaseous-Phase. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: JEH. Product type: Plethysmograph, Volume. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1760. Implant flag: N. Life-sustain/support flag: N.

Official code: JEI. Product type: Claw, Foreign Body, Bronchoscope (Non-Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: JEJ. Product type: Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: JEK. Product type: Forceps, Biopsy, Bronchoscope (Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: JEL. Product type: Curette, Biopsy, Bronchoscope (Rigid). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: JEO. Product type: Measurer, Gingival Fluid. Official classification: Class I. Official category: Dental. Regulation number: 872.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: JEP. Product type: Retainer, Matrix. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: JEQ. Product type: Toothbrush, Powered. Official classification: Class I. Official category: Dental. Regulation number: 872.6865. Implant flag: N. Life-sustain/support flag: N.

Official code: JER. Product type: Cleaner, Denture, Mechanical. Official classification: Class I. Official category: Dental. Regulation number: 872.3530. Implant flag: N. Life-sustain/support flag: N.

Official code: JES. Product type: Floss, Dental. Official classification: Class I. Official category: Dental. Regulation number: 872.6390. Implant flag: N. Life-sustain/support flag: N.

Official code: JET. Product type: Pick, Massaging. Official classification: Class I. Official category: Dental. Regulation number: 872.6650. Implant flag: N. Life-sustain/support flag: N.

Official code: JEW. Product type: Tip, Rubber, Oral Hygiene. Official classification: Class I. Official category: Dental. Regulation number: 872.6650. Implant flag: N. Life-sustain/support flag: N.

Official code: JEX. Product type: Plier, Orthodontic. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. Implant flag: N. Life-sustain/support flag: N.

Official code: JEY. Product type: Plate, Bone. Official classification: Class II. Official category: Dental. Regulation number: 872.4760. Implant flag: Y. Life-sustain/support flag: N.

Official code: JEZ. Product type: Monitor, Lung Water Measurement. Official classification: Class III. Official category: Anesthesiology. Regulation number: 868.2450. Implant flag: N. Life-sustain/support flag: N.

Official code: JFA. Product type: Exerciser, Finger, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5410. Implant flag: N. Life-sustain/support flag: N.

Official code: JFB. Product type: Table, Physical Therapy, Multi Function. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: JFC. Product type: System, Pressure Measurement, Intermittent. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: JFE. Product type: Valve, Switching (Ploss). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1965. Implant flag: N. Life-sustain/support flag: N.

Official code: JFH. Product type: Acid Phosphatase (Prostatic), Tartrate Inhibited. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1020. Implant flag: N. Life-sustain/support flag: N.

Official code: JFJ. Product type: Catalytic Methods, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: JFL. Product type: Ph Rate Measurement, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: JFM. Product type: Enzymatic Method, Bilirubin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1110. Implant flag: N. Life-sustain/support flag: N.

Official code: JFN. Product type: Atomic Absorption, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: JFO. Product type: Fluorometric, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: JFP. Product type: Electrode, Ion Specific, Calcium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1145. Implant flag: N. Life-sustain/support flag: N.

Official code: JFQ. Product type: P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: JFR. Product type: Indirect Copper Assay, Ceruloplasmin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: JFS. Product type: Coulometric, Chloride. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: JFT. Product type: Fluorometric, Cortisol. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1205. Implant flag: N. Life-sustain/support flag: N.

Official code: JFY. Product type: Enzymatic Method, Creatinine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1225. Implant flag: N. Life-sustain/support flag: N.

Official code: JGC. Product type: Tryptophan Measurement (Colorimetric), Globulin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: JGD. Product type: Nephelometric Method, Globulin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: JGE. Product type: Turbidimetric Method, Globulin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: JGF. Product type: Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1445. Implant flag: N. Life-sustain/support flag: N.

Official code: JGG. Product type: L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1460. Implant flag: N. Life-sustain/support flag: N.

Official code: JGI. Product type: Atomic Absorption, Magnesium. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1495. Implant flag: N. Life-sustain/support flag: N.

Official code: JGJ. Product type: Photometric Method, Magnesium. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1495. Implant flag: N. Life-sustain/support flag: N.

Official code: JGK. Product type: Ferric Chloride, Phenylketones (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1560. Implant flag: N. Life-sustain/support flag: N.

Official code: JGM. Product type: Flame Photometry, Potassium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: JGP. Product type: Lowry (Colorimetric), Total Protein. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1635. Implant flag: N. Life-sustain/support flag: N.

Official code: JGQ. Product type: Turbidimetric, Total Protein. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1635. Implant flag: N. Life-sustain/support flag: N.

Official code: JGR. Product type: Refractometric, Total Protein. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1635. Implant flag: N. Life-sustain/support flag: N.

Official code: JGS. Product type: Electrode, Ion Specific, Sodium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1665. Implant flag: N. Life-sustain/support flag: N.

Official code: JGT. Product type: Flame Photometry, Sodium. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1665. Implant flag: N. Life-sustain/support flag: N.

Official code: JGW. Product type: Fluorometric Method, Triglycerides. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1705. Implant flag: N. Life-sustain/support flag: N.

Official code: JGX. Product type: Turbidimetric Method, Triglycerides. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1705. Implant flag: N. Life-sustain/support flag: N.

Official code: JGY. Product type: Colorimetric Method, Triglycerides. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1705. Implant flag: N. Life-sustain/support flag: N.

Official code: JGZ. Product type: O-Phthalaldehyde, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: JHA. Product type: Acid, Uric, Uricase (Gasometric). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. Implant flag: N. Life-sustain/support flag: N.

Official code: JHC. Product type: Acid, Uric, Uricase (Oxygen Rate). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. Implant flag: N. Life-sustain/support flag: N.

Official code: JHD. Product type: Fluorometric Method, 17-Hydroxycorticosteroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: JHE. Product type: Radioassay, 17-Hydroxycorticosteroids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1385. Implant flag: N. Life-sustain/support flag: N.

Official code: JHF. Product type: Colorimetric Method, Lecithin/Sphingomyelin Ratio. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1455. Implant flag: N. Life-sustain/support flag: N.

Official code: JHG. Product type: Chromatographic Separation, Lecithin/Sphingomyelin Ratio. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1455. Implant flag: N. Life-sustain/support flag: N.

Official code: JHH. Product type: Electrophoretic Method, Lecithin/Sphingomyelin Ratio. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1455. Implant flag: N. Life-sustain/support flag: N.

Official code: JHI. Product type: Visual, Pregnancy Hcg, Prescription Use. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1155. Implant flag: N. Life-sustain/support flag: N.

Official code: JHJ. Product type: Agglutination Method, Human Chorionic Gonadotropin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1155. Implant flag: N. Life-sustain/support flag: N.

Official code: JHL. Product type: Microdensitometry Method, Lipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JHM. Product type: Colorimetric Method, Lipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JHN. Product type: Turbidimetric Method, Lipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JHO. Product type: Electrophoretic Separation, Lipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JHP. Product type: Radial Immunodiffusion, Lipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JHQ. Product type: Nephelometric Method, Lipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JHR. Product type: Radioimmunoassay, Immunoglobulins (D, E). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: JHS. Product type: Differential Rate Kinetic Method, Cpk Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: JHT. Product type: Chromatographic Separation, Cpk Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: JHW. Product type: U.V. Method, Cpk Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: JHX. Product type: Fluorometric Method, Cpk Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: JHY. Product type: Colorimetric Method, Cpk Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: JIA. Product type: Enzymatic Methods, Galactose. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1310. Implant flag: N. Life-sustain/support flag: N.

Official code: JIB. Product type: U.V. Method, Galactose. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1310. Implant flag: N. Life-sustain/support flag: N.

Official code: JIC. Product type: Colorimetric Method, Galactose. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1310. Implant flag: N. Life-sustain/support flag: N.

Official code: JID. Product type: Photometric Method, Ammonia. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1065. Implant flag: N. Life-sustain/support flag: N.

Official code: JIE. Product type: Method, Ion-Exchange, Ammonia. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1065. Implant flag: N. Life-sustain/support flag: N.

Official code: JIF. Product type: Enzymatic Method, Ammonia. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1065. Implant flag: N. Life-sustain/support flag: N.

Official code: JIG. Product type: Electrode, Ion-Specific Method, Ammonia. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1065. Implant flag: N. Life-sustain/support flag: N.

Official code: JIH. Product type: Flame Photometry, Lithium. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3560. Implant flag: N. Life-sustain/support flag: N.

Official code: JII. Product type: Atomic Absorption, Lithium. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3560. Implant flag: N. Life-sustain/support flag: N.

Official code: JIJ. Product type: Wet Ash Method, Protein-Bound Iodine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: JIK. Product type: Dry Ash Method, Protein-Bound Iodine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: JIL. Product type: Method, Enzymatic, Glucose (Urinary, Non-Quantitative). Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1340. Implant flag: N. Life-sustain/support flag: N.

Official code: JIM. Product type: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative). Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1340. Implant flag: N. Life-sustain/support flag: N.

Official code: JIN. Product type: Nitroprusside, Ketones (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1435. Implant flag: N. Life-sustain/support flag: N.

Official code: JIO. Product type: Blood, Occult, Colorimetric, In Urine. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. Implant flag: N. Life-sustain/support flag: N.

Official code: JIP. Product type: Blood, Occult, Enzymatic Method, In Urine. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. Implant flag: N. Life-sustain/support flag: N.

Official code: JIQ. Product type: Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1645. Implant flag: N. Life-sustain/support flag: N.

Official code: JIR. Product type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1645. Implant flag: N. Life-sustain/support flag: N.

Official code: JIS. Product type: Calibrator, Primary. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1150. Implant flag: N. Life-sustain/support flag: N.

Official code: JIT. Product type: Calibrator, Secondary. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1150. Implant flag: N. Life-sustain/support flag: N.

Official code: JIW. Product type: Calibrator, Surrogate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1150. Implant flag: N. Life-sustain/support flag: N.

Official code: JIX. Product type: Calibrator, Multi-Analyte Mixture. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1150. Implant flag: N. Life-sustain/support flag: N.

Official code: JIY. Product type: Photometric Method, Iron (Non-Heme). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: JIZ. Product type: Atomic Absorption, Iron (Non-Heme). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: JJA. Product type: Radio-Labeled Iron Method, Iron (Non-Heme). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1410. Implant flag: N. Life-sustain/support flag: N.

Official code: JJB. Product type: Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1115. Implant flag: N. Life-sustain/support flag: N.

Official code: JJC. Product type: Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2150. Implant flag: N. Life-sustain/support flag: N.

Official code: JJE. Product type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2160. Implant flag: N. Life-sustain/support flag: N.

Official code: JJF. Product type: Analyzer, Chemistry, Micro, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2170. Implant flag: N. Life-sustain/support flag: N.

Official code: JJG. Product type: Analyzer, Chemistry, Centrifugal, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2140. Implant flag: N. Life-sustain/support flag: N.

Official code: JJH. Product type: Clinical Sample Concentrator. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2310. Implant flag: N. Life-sustain/support flag: N.

Official code: JJI. Product type: Analyzer, Enzyme, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2500. Implant flag: N. Life-sustain/support flag: N.

Official code: JJJ. Product type: Counter (Beta, Gamma) For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2320. Implant flag: N. Life-sustain/support flag: N.

Official code: JJK. Product type: Oncometer, Plasma, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2720. Implant flag: N. Life-sustain/support flag: N.

Official code: JJL. Product type: Plasma Viscometer For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2920. Implant flag: N. Life-sustain/support flag: N.

Official code: JJM. Product type: Osmometer For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2730. Implant flag: N. Life-sustain/support flag: N.

Official code: JJN. Product type: Apparatus, Electrophoresis, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2485. Implant flag: N. Life-sustain/support flag: N.

Official code: JJO. Product type: Flame Emission Photometer For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2540. Implant flag: N. Life-sustain/support flag: N.

Official code: JJP. Product type: Electrode, Ion Selective (Non-Specified). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JJQ. Product type: Colorimeter, Photometer, Spectrophotometer For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2300. Implant flag: N. Life-sustain/support flag: N.

Official code: JJR. Product type: Electrolyte Controls (Assayed And Unassayed). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JJS. Product type: Controls For Blood-Gases, (Assayed And Unassayed). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JJT. Product type: Enzyme Controls (Assayed And Unassayed). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JJW. Product type: Urinalysis Controls (Assayed And Unassayed). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JJX. Product type: Single (Specified) Analyte Controls (Assayed And Unassayed). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JJY. Product type: Multi-Analyte Controls, All Kinds (Assayed). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: JKA. Product type: Tubes, Vials, Systems, Serum Separators, Blood Collection. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. Implant flag: N. Life-sustain/support flag: N.

Official code: JKB. Product type: Radioimmunoassay, Compound S (11-Deoxycortisol). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1185. Implant flag: N. Life-sustain/support flag: N.

Official code: JKC. Product type: Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1245. Implant flag: N. Life-sustain/support flag: N.

Official code: JKD. Product type: Radioimmunoassay, C-Peptides Of Proinsulin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1135. Implant flag: N. Life-sustain/support flag: N.

Official code: JKF. Product type: Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1380. Implant flag: N. Life-sustain/support flag: N.

Official code: JKG. Product type: L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1420. Implant flag: N. Life-sustain/support flag: N.

Official code: JKH. Product type: Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1420. Implant flag: N. Life-sustain/support flag: N.

Official code: JKJ. Product type: Fluorometric Measurement, Porphyrins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1595. Implant flag: N. Life-sustain/support flag: N.

Official code: JKL. Product type: Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1060. Implant flag: N. Life-sustain/support flag: N.

Official code: JKM. Product type: Immunochemical, Bence-Jones Protein. Official classification: Class II. Official category: Immunology. Regulation number: 866.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: JKP. Product type: Chromium-51, Blood Volume. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1130. Implant flag: N. Life-sustain/support flag: N.

Official code: JKQ. Product type: Gold Chloride (Colorimetric), Bromide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: JKR. Product type: Radioimmunoassay, Calcitonin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1140. Implant flag: N. Life-sustain/support flag: N.

Official code: JKS. Product type: Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: JKT. Product type: Gas Chromatograph, Carbon-Monoxide. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: JKW. Product type: N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1180. Implant flag: N. Life-sustain/support flag: N.

Official code: JKX. Product type: N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1180. Implant flag: N. Life-sustain/support flag: N.

Official code: JKY. Product type: Oxalydihydrazide (Spectroscopic), Copper. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1190. Implant flag: N. Life-sustain/support flag: N.

Official code: JKZ. Product type: Diethyldithiocarbamate (Colorimetric), Copper. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1190. Implant flag: N. Life-sustain/support flag: N.

Official code: JLA. Product type: Conversion To Creatinine, Creatine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1210. Implant flag: N. Life-sustain/support flag: N.

Official code: JLB. Product type: Atp And Creatine Kinase (Enzymatic), Creatine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1210. Implant flag: N. Life-sustain/support flag: N.

Official code: JLC. Product type: Nitroprusside Reaction (Qualitative, Urine), Cystine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1240. Implant flag: N. Life-sustain/support flag: N.

Official code: JLD. Product type: Chromatographic, Cystine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1240. Implant flag: N. Life-sustain/support flag: N.

Official code: JLE. Product type: Radioimmunoassay, Desoxycorticosterone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: JLF. Product type: Radioimmunoassay, Etiocholanolone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1285. Implant flag: N. Life-sustain/support flag: N.

Official code: JLG. Product type: Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1290. Implant flag: N. Life-sustain/support flag: N.

Official code: JLH. Product type: Titrimetric, Fatty Acids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1290. Implant flag: N. Life-sustain/support flag: N.

Official code: JLI. Product type: Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1305. Implant flag: N. Life-sustain/support flag: N.

Official code: JLJ. Product type: Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1315. Implant flag: N. Life-sustain/support flag: N.

Official code: JLK. Product type: Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1320. Implant flag: N. Life-sustain/support flag: N.

Official code: JLL. Product type: Tubeless Analysis, Gastric Acidity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1320. Implant flag: N. Life-sustain/support flag: N.

Official code: JLM. Product type: Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JLN. Product type: Chromatographic, Glutathione. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1365. Implant flag: N. Life-sustain/support flag: N.

Official code: JLO. Product type: Enzymatic (Glutathione Reductase), Glutathione. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1365. Implant flag: N. Life-sustain/support flag: N.

Official code: JLP. Product type: Spectrophotometric Method, Pregnanediol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1605. Implant flag: N. Life-sustain/support flag: N.

Official code: JLQ. Product type: Spectrophotometric Method, Pregnanetriol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: JLR. Product type: Gas Chromatography, Pregnanetriol. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: JLS. Product type: Radioimmunoassay, Progesterone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: JLT. Product type: Acid, Pyruvic, Enzymatic (U.V.). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1655. Implant flag: N. Life-sustain/support flag: N.

Official code: JLW. Product type: Radioimmunoassay, Thyroid-Stimulating Hormone. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1690. Implant flag: N. Life-sustain/support flag: N.

Official code: JLX. Product type: Radioimmunoassay, 17-Hydroxyprogesterone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1395. Implant flag: N. Life-sustain/support flag: N.

Official code: JLY. Product type: Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1255. Implant flag: N. Life-sustain/support flag: N.

Official code: JLZ. Product type: Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1255. Implant flag: N. Life-sustain/support flag: N.

Official code: JMA. Product type: Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1095. Implant flag: N. Life-sustain/support flag: N.

Official code: JMB. Product type: Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JMC. Product type: Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: JMD. Product type: Radioimmunoassay, Total Estrogens, Nonpregnancy. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1275. Implant flag: N. Life-sustain/support flag: N.

Official code: JME. Product type: Radioimmunoassay, Glucagon. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1335. Implant flag: N. Life-sustain/support flag: N.

Official code: JMF. Product type: Radioimmunoassay, Human Placental Lactogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1585. Implant flag: N. Life-sustain/support flag: N.

Official code: JMG. Product type: Radioimmunoassay (Two-Site Solid Phase), Ferritin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5340. Implant flag: N. Life-sustain/support flag: N.

Official code: JMH. Product type: Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase. Official classification: Class II. Official category: Hematology. Regulation number: 864.7375. Implant flag: N. Life-sustain/support flag: N.

Official code: JMI. Product type: Chromatographic, Histidine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1375. Implant flag: N. Life-sustain/support flag: N.

Official code: JMJ. Product type: Microbiological, Histidine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1375. Implant flag: N. Life-sustain/support flag: N.

Official code: JMK. Product type: Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1380. Implant flag: N. Life-sustain/support flag: N.

Official code: JMM. Product type: Column Chromatography & Color Development, Hydroxyproline. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1400. Implant flag: N. Life-sustain/support flag: N.

Official code: JMN. Product type: Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1400. Implant flag: N. Life-sustain/support flag: N.

Official code: JMO. Product type: Ferrozine (Colorimetric) Iron Binding Capacity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1415. Implant flag: N. Life-sustain/support flag: N.

Official code: JMQ. Product type: M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1490. Implant flag: N. Life-sustain/support flag: N.

Official code: JMR. Product type: Immunochemical, Lysozyme (Muramidase). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1490. Implant flag: N. Life-sustain/support flag: N.

Official code: JMS. Product type: Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: JMT. Product type: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1510. Implant flag: N. Life-sustain/support flag: N.

Official code: JMW. Product type: 2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1515. Implant flag: N. Life-sustain/support flag: N.

Official code: JMX. Product type: Ninhydrin, Nitrogen (Amino-Nitrogen). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1515. Implant flag: N. Life-sustain/support flag: N.

Official code: JMY. Product type: Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1535. Implant flag: N. Life-sustain/support flag: N.

Official code: JMZ. Product type: Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1540. Implant flag: N. Life-sustain/support flag: N.

Official code: JNA. Product type: Vapor Pressure, Osmolality Of Serum & Urine. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1540. Implant flag: N. Life-sustain/support flag: N.

Official code: JNB. Product type: Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1555. Implant flag: N. Life-sustain/support flag: N.

Official code: JNC. Product type: Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1555. Implant flag: N. Life-sustain/support flag: N.

Official code: JND. Product type: Nadp Reduction, 6-Phosphogluconate Dehydrogenase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1565. Implant flag: N. Life-sustain/support flag: N.

Official code: JNE. Product type: Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: JNF. Product type: Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1590. Implant flag: N. Life-sustain/support flag: N.

Official code: JNG. Product type: Radioimmunoassay, Pregnenolone. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1615. Implant flag: N. Life-sustain/support flag: N.

Official code: JNJ. Product type: Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: JNK. Product type: Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1670. Implant flag: N. Life-sustain/support flag: N.

Official code: JNL. Product type: Immunochemical, Thyroglobulin Autoantibody. Official classification: Class II. Official category: Immunology. Regulation number: 866.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: JNM. Product type: Immunochemical, Transferrin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: JNN. Product type: P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1725. Implant flag: N. Life-sustain/support flag: N.

Official code: JNO. Product type: N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1725. Implant flag: N. Life-sustain/support flag: N.

Official code: JNP. Product type: Infrared Spectroscopy Measurement, Urinary Calculi (Stone). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1780. Implant flag: N. Life-sustain/support flag: N.

Official code: JNQ. Product type: Qualitative Chemical Reactions, Urinary Calculi (Stone). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1780. Implant flag: N. Life-sustain/support flag: N.

Official code: JNS. Product type: Stannous Chloride - Hydrazine, Phospholipids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1575. Implant flag: N. Life-sustain/support flag: N.

Official code: JNT. Product type: Chromatographic, Phospholipids. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1575. Implant flag: N. Life-sustain/support flag: N.

Official code: JNX. Product type: Membrane Osmometry, Plasma Oncometry. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1530. Implant flag: N. Life-sustain/support flag: N.

Official code: JNY. Product type: Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1720. Implant flag: N. Life-sustain/support flag: N.

Official code: JNZ. Product type: Fluorometric, Uroporphyrin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1790. Implant flag: N. Life-sustain/support flag: N.

Official code: JOA. Product type: Acid, Trifluoroacetic, Vitamin A, Hexane Extraction. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1805. Implant flag: N. Life-sustain/support flag: N.

Official code: JOB. Product type: Hexane Extraction, Fluorescence, Vitamin E. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1815. Implant flag: N. Life-sustain/support flag: N.

Official code: JOC. Product type: Colorimetric, Xylose. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1820. Implant flag: N. Life-sustain/support flag: N.

Official code: JOD. Product type: Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4270. Implant flag: N. Life-sustain/support flag: N.

Official code: JOF. Product type: Polymer, Ent Synthetic, Porous Polyethylene. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: JOH. Product type: Tube Tracheostomy And Tube Cuff. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5800. Implant flag: N. Life-sustain/support flag: Y.

Official code: JOJ. Product type: Indicator, Physical/Chemical Sterilization Process. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: JOK. Product type: Scissors, Medical, Disposable. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6820. Implant flag: N. Life-sustain/support flag: N.

Official code: JOL. Product type: Catheter And Tip, Suction. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: JOM. Product type: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2780. Implant flag: N. Life-sustain/support flag: N.

Official code: JON. Product type: Transducer, Apex Cardiographic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2840. Implant flag: N. Life-sustain/support flag: N.

Official code: JOO. Product type: Transducer, Heart Sound. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2860. Implant flag: N. Life-sustain/support flag: N.

Official code: JOP. Product type: Transducer, Ultrasonic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2880. Implant flag: N. Life-sustain/support flag: N.

Official code: JOQ. Product type: Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1750. Implant flag: N. Life-sustain/support flag: Y.

Official code: JOR. Product type: Generator, Pulsatile Flow, Cardiopulmonary Bypass. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.4320. Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. Implant flag: N. Life-sustain/support flag: N.

Official code: JOS. Product type: Electrode, Electrosurgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: JOT. Product type: Electrode, Gel, Electrosurgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: JOW. Product type: Sleeve, Limb, Compressible. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: JOX. Product type: Analyzer, Heparin, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5680. Implant flag: N. Life-sustain/support flag: N.

Official code: JOY. Product type: Device, Automated Cell-Locating. Official classification: Class II. Official category: Hematology. Regulation number: 864.5260. Implant flag: N. Life-sustain/support flag: N.

Official code: JOZ. Product type: System, Automated Platelet Aggregation. Official classification: Class II. Official category: Hematology. Regulation number: 864.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: JPA. Product type: System, Multipurpose For In Vitro Coagulation Studies. Official classification: Class II. Official category: Hematology. Regulation number: 864.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: JPB. Product type: Hemoglobin M. Official classification: Class II. Official category: Hematology. Regulation number: 864.7415. Implant flag: N. Life-sustain/support flag: N.

Official code: JPC. Product type: Hemoglobin F Quantitation. Official classification: Class II. Official category: Hematology. Regulation number: 864.7455. Implant flag: N. Life-sustain/support flag: N.

Official code: JPD. Product type: Hemoglobin A2 Quantitation. Official classification: Class II. Official category: Hematology. Regulation number: 864.7400. Implant flag: N. Life-sustain/support flag: N.

Official code: JPE. Product type: Antithrombin Iii, Two Stage Clotting Time Assay. Official classification: Class II. Official category: Hematology. Regulation number: 864.7060. Implant flag: N. Life-sustain/support flag: N.

Official code: JPF. Product type: Prothrombin-Proconvertin And Thrombotest. Official classification: Class II. Official category: Hematology. Regulation number: 864.7735. Implant flag: N. Life-sustain/support flag: N.

Official code: JPH. Product type: Test, Erythrocyte Sedimentation Rate. Official classification: Class I. Official category: Hematology. Regulation number: 864.6700. Implant flag: N. Life-sustain/support flag: N.

Official code: JPI. Product type: Device, Hematocrit Measuring. Official classification: Class II. Official category: Hematology. Regulation number: 864.6400. Implant flag: N. Life-sustain/support flag: N.

Official code: JPJ. Product type: Red-Cell Indices, Calculated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: JPK. Product type: Mixture, Hematology Quality Control. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. Implant flag: N. Life-sustain/support flag: N.

Official code: JPW. Product type: Pump, Nebulizer, Electrically Powered. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: JPZ. Product type: Colorimetric Method, Gamma-Glutamyl Transpeptidase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1360. Implant flag: N. Life-sustain/support flag: N.

Official code: JQA. Product type: Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1360. Implant flag: N. Life-sustain/support flag: N.

Official code: JQB. Product type: Kinetic Method, Gamma-Glutamyl Transpeptidase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1360. Implant flag: N. Life-sustain/support flag: N.

Official code: JQC. Product type: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JQD. Product type: Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1415. Implant flag: N. Life-sustain/support flag: N.

Official code: JQE. Product type: Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1415. Implant flag: N. Life-sustain/support flag: N.

Official code: JQF. Product type: Bathophenanthroline, Iron Binding Capacity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1415. Implant flag: N. Life-sustain/support flag: N.

Official code: JQG. Product type: Radiometric, Fe59, Iron Binding Capacity. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1415. Implant flag: N. Life-sustain/support flag: N.

Official code: JQH. Product type: Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1515. Implant flag: N. Life-sustain/support flag: N.

Official code: JQI. Product type: Rotating Disc, Plasma Viscometry. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: JQJ. Product type: Densitometeric, Protein Fractionation. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: JQK. Product type: Immunodiffusion, Protein Fractionation. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: JQL. Product type: Spectrophotometric, Uroporphyrin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1790. Implant flag: N. Life-sustain/support flag: N.

Official code: JQM. Product type: P-Bromoaniline, Xylose. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1820. Implant flag: N. Life-sustain/support flag: N.

Official code: JQN. Product type: Colorimetric, Mucopolysaccharides. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1505. Implant flag: N. Life-sustain/support flag: N.

Official code: JQO. Product type: Balance, Analytical. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JQP. Product type: Calculator/Data Processing Module, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2100. Implant flag: N. Life-sustain/support flag: N.

Official code: JQQ. Product type: Dialyzer. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JQT. Product type: Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2400. Implant flag: N. Life-sustain/support flag: N.

Official code: JQW. Product type: Station, Pipetting And Diluting, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2750. Implant flag: N. Life-sustain/support flag: N.

Official code: JQX. Product type: Nephelometer, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: JQY. Product type: Ph Meter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JQZ. Product type: Polarimeter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRA. Product type: Microtitrator, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2680. Implant flag: N. Life-sustain/support flag: N.

Official code: JRB. Product type: Micro Mixer. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRC. Product type: Micro Pipette. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRE. Product type: Refractometer For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: JRG. Product type: Block, Heating. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRI. Product type: Cuvette, Thermostated. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRJ. Product type: Unit, Drying. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRK. Product type: Evaporator. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRL. Product type: Unit, Filter, Membrane. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRM. Product type: Freezer. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRO. Product type: Blender/Mixer. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRQ. Product type: Shaker/Stirrer. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRR. Product type: Regulator, Temperature. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRS. Product type: Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: JRW. Product type: Antisera, Fluorescent, B. Parapertussis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3065. Implant flag: N. Life-sustain/support flag: N.

Official code: JRY. Product type: Antiserum, Fluorescent, Epstein-Barr Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: JRZ. Product type: Media, Culture, Amino Acid Assay. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2350. Implant flag: N. Life-sustain/support flag: N.

Official code: JSA. Product type: Culture Media, Antibiotic Assay. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2350. Implant flag: N. Life-sustain/support flag: N.

Official code: JSB. Product type: Culture Media, Vitamin Assay. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2350. Implant flag: N. Life-sustain/support flag: N.

Official code: JSC. Product type: Culture Media, General Nutrient Broth. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2350. Implant flag: N. Life-sustain/support flag: N.

Official code: JSD. Product type: Culture Media, Selective Broth. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: JSE. Product type: Culture Media, Multiple Biochemical Test. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2320. Implant flag: N. Life-sustain/support flag: N.

Official code: JSF. Product type: Culture Media, Single Biochemical Test. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2320. Implant flag: N. Life-sustain/support flag: N.

Official code: JSG. Product type: Culture Media, Non-Selective And Non-Differential. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2300. Implant flag: N. Life-sustain/support flag: N.

Official code: JSH. Product type: Culture Media, Non-Selective And Differential. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2320. Implant flag: N. Life-sustain/support flag: N.

Official code: JSI. Product type: Culture Media, Selective And Differential. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: JSJ. Product type: Culture Media, Selective And Non-Differential. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: JSK. Product type: Supplement, Culture Media. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2450. Implant flag: N. Life-sustain/support flag: N.

Official code: JSL. Product type: Culture Media, Anaerobic Transport. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2390. Implant flag: N. Life-sustain/support flag: N.

Official code: JSM. Product type: Culture Media, Non-Propagating Transport. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2390. Implant flag: N. Life-sustain/support flag: N.

Official code: JSN. Product type: Culture Media, Propagating Transport. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2390. Implant flag: N. Life-sustain/support flag: N.

Official code: JSO. Product type: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: JSP. Product type: Kit, Anaerobic Identification. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JSQ. Product type: Chromatography For Bacterial Identification. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: JSR. Product type: Kit, Identification, Dermatophyte. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JSS. Product type: Kit, Identification, Enterobacteriaceae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JST. Product type: Kit, Fastidious Organisms. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JSW. Product type: Kit, Identification, Glucose Nonfermenter. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JSX. Product type: Kit, Identification, Neisseria Gonorrhoeae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JSY. Product type: Kit, Identification, Mycobacteria. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JSZ. Product type: Kit, Identification, Pseudomonas. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JTA. Product type: Monitor, Microbial Growth. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2560. Implant flag: N. Life-sustain/support flag: N.

Official code: JTB. Product type: Device, Media Dispensing/Stacking. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2440. Implant flag: N. Life-sustain/support flag: N.

Official code: JTC. Product type: Device, Microtiter Diluting/Dispensing. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2500. Implant flag: N. Life-sustain/support flag: N.

Official code: JTL. Product type: Plasma, Coagulase, Human, Horse And Rabbit. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2160. Implant flag: N. Life-sustain/support flag: N.

Official code: JTM. Product type: Anaerobic Box Glove. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2120. Implant flag: N. Life-sustain/support flag: N.

Official code: JTN. Product type: Susceptibility Test Discs, Antimicrobial. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: JTO. Product type: Discs, Strips And Reagents, Microorganism Differentiation. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JTQ. Product type: Bath, Incubators/Water, All. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2540. Implant flag: N. Life-sustain/support flag: N.

Official code: JTR. Product type: Kit, Quality Control For Culture Media. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2480. Implant flag: N. Life-sustain/support flag: N.

Official code: JTS. Product type: Stains, Microbiologic. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: JTT. Product type: Susceptibility Test Powders, Antimicrobial. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: JTW. Product type: System, Transport, Aerobic. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: JTX. Product type: Transport Systems, Anaerobic. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: JTY. Product type: Culture Media, For Isolation Of Pathogenic Neisseria. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2410. Implant flag: N. Life-sustain/support flag: N.

Official code: JTZ. Product type: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: JWH. Product type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3560. Implant flag: Y. Life-sustain/support flag: N.

Official code: JWI. Product type: Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3800. Implant flag: Y. Life-sustain/support flag: N.

Official code: JWJ. Product type: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3800. Implant flag: Y. Life-sustain/support flag: N.

Official code: JWK. Product type: Antigen, Positive Control, Cryptococcus Neoformans. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: JWL. Product type: Antigen, Treponema Pallidum For Fta-Abs Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: JWM. Product type: System, Tomographic, Nuclear. Official classification: Class II. Official category: Radiology. Regulation number: 892.1310. Implant flag: N. Life-sustain/support flag: N.

Official code: JWO. Product type: Device, Blood Volume Measuring. Official classification: Class II. Official category: Hematology. Regulation number: 864.5950. Implant flag: N. Life-sustain/support flag: N.

Official code: JWR. Product type: Atp Release (Luminescence). Official classification: Class I. Official category: Hematology. Regulation number: 864.7040. Implant flag: N. Life-sustain/support flag: N.

Official code: JWT. Product type: Antigen, Cf, Aspergillus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: JWW. Product type: Antigen, Cf, B. Dermatitidis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: JWX. Product type: Kit, Screening, Staphylococcus Aureus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JWY. Product type: Manual Antimicrobial Susceptibility Test Systems. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: JWZ. Product type: Kit, Screening, Trichomonas. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JXA. Product type: Kit, Screening, Urine. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JXB. Product type: Kit, Identification, Yeast. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JXC. Product type: Kit, Screening, Yeast. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: JXE. Product type: Device, Nerve Conduction Velocity Measurement. Official classification: Class II. Official category: Neurology. Regulation number: 882.1550. Implant flag: N. Life-sustain/support flag: N.

Official code: JXF. Product type: Plethysmograph, Ocular. Official classification: Class III. Official category: Neurology. Regulation number: 882.1790. PMAs to be filed by 9/21/04 (69 FR 34920 (6/23/04)) Implant flag: N. Life-sustain/support flag: N.

Official code: JXG. Product type: Shunt, Central Nervous System And Components. Official classification: Class II. Official category: Neurology. Regulation number: 882.5550. Implant flag: Y. Life-sustain/support flag: N.

Official code: JXH. Product type: Methyl Methacrylate For Aneurysmorrhaphy. Official classification: Class II. Official category: Neurology. Regulation number: 882.5030. Implant flag: Y. Life-sustain/support flag: N.

Official code: JXI. Product type: Cuff, Nerve. Official classification: Class II. Official category: Neurology. Regulation number: 882.5275. Implant flag: Y. Life-sustain/support flag: N.

Official code: JXK. Product type: Cranial Electrotherapy Stimulator To Treat Depression. Official classification: Class III. Official category: Neurology. Regulation number: 882.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: JXL. Product type: Block, Bite. Official classification: Class II. Official category: Neurology. Regulation number: 882.5070. Implant flag: N. Life-sustain/support flag: N.

Official code: JXM. Product type: Enzyme Immunoassay, Benzodiazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3170. Implant flag: N. Life-sustain/support flag: N.

Official code: JXN. Product type: Enzyme Immunoassay, Propoxyphene. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: JXO. Product type: Enzyme Immunoassay, Cocaine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: JXQ. Product type: Monitor, U.V., Glc. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: JXR. Product type: Atomic Absorption Spectrophotometer, General Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2850. Implant flag: N. Life-sustain/support flag: N.

Official code: JXS. Product type: Block, Cutting, Ent, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JXT. Product type: Crimper, Wire, Ent, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JXW. Product type: Die, Wire Bending, Ent, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JXX. Product type: Forceps, Wire Closure, Ent, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JXY. Product type: Jig, Piston Cutting, Ent, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JXZ. Product type: Punch, Gelfoam, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JYA. Product type: Scissors, Wire Cutting, Ent, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JYB. Product type: Vise, Ossicular Finger, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: JYC. Product type: Cannula, Ear. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: JYD. Product type: Chisel, Mastoid. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: JYE. Product type: Chisel, Middle-Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYF. Product type: Clamp, Ossicle Holding. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYG. Product type: Curette, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYH. Product type: Excavator, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYI. Product type: Gauge, Mastoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYJ. Product type: Gauge, Measuring. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYK. Product type: Holder, Ear Speculum. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: JYL. Product type: Hook, Microsurgical Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYM. Product type: Inserter, Myringotomy Tube. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYN. Product type: Inserter, Sacculotomy Tack. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYO. Product type: Knife, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYP. Product type: Knife, Myringotomy. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYQ. Product type: Loop, Wire. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYR. Product type: Nipper, Malleus. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYS. Product type: Perforator, Ear-Lobe. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYT. Product type: Pick, Microsurgical Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYW. Product type: Press, Vein. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYX. Product type: Punch, Attic. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYY. Product type: Rasp, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JYZ. Product type: Rod, Measuring Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZA. Product type: Rongeur, Mastoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZB. Product type: Scissors, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZC. Product type: Searcher, Mastoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZD. Product type: Snare, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZE. Product type: Spoon, Ear. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZF. Product type: Tube, Ear Suction. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZG. Product type: System, Test, Beta-2-Microglobulin Immunological. Official classification: Class II. Official category: Immunology. Regulation number: 866.5630. Implant flag: N. Life-sustain/support flag: N.

Official code: JZH. Product type: Factor B, Antigen, Antiserum, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5320. Implant flag: N. Life-sustain/support flag: N.

Official code: JZJ. Product type: Prealbumin, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5060. Implant flag: N. Life-sustain/support flag: N.

Official code: JZO. Product type: System, Test, Thyroid Autoantibody. Official classification: Class II. Official category: Immunology. Regulation number: 866.5870. Implant flag: N. Life-sustain/support flag: N.

Official code: JZP. Product type: Plates, Ouchterlony Agar. Official classification: Class I. Official category: Immunology. Regulation number: 866.4600. Implant flag: N. Life-sustain/support flag: N.

Official code: JZQ. Product type: Plates And Equipment, Radial Immunodiffusion. Official classification: Class I. Official category: Immunology. Regulation number: 866.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: JZR. Product type: Support Gels. Official classification: Class I. Official category: Immunology. Regulation number: 866.4900. Implant flag: N. Life-sustain/support flag: N.

Official code: JZS. Product type: Electrophoresis Instrumentation. Official classification: Class I. Official category: Immunology. Regulation number: 866.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: JZT. Product type: Fluorometer. Official classification: Class I. Official category: Immunology. Regulation number: 866.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: JZW. Product type: Nephelometer. Official classification: Class I. Official category: Immunology. Regulation number: 866.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: JZX. Product type: Equipment, Rocket Immunoelectrophoresis. Official classification: Class I. Official category: Immunology. Regulation number: 866.4830. Implant flag: N. Life-sustain/support flag: N.

Official code: JZY. Product type: Knife, Laryngeal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: JZZ. Product type: Saw, Laryngeal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAA. Product type: Set, Laryngeal Injection. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAB. Product type: Trocar, Laryngeal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAC. Product type: Tube, Laryngectomy. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAD. Product type: Elevator, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAE. Product type: Forceps, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAG. Product type: Holder, Speculum, Ent. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: KAH. Product type: Microrule, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAI. Product type: Mirror, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAJ. Product type: Mobilizer, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAK. Product type: Probe, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAL. Product type: Retractor, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAM. Product type: Cannula, Sinus. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: KAN. Product type: Chisel, Nasal. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: KAO. Product type: Curette, Ethmoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAP. Product type: Curette, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAQ. Product type: Gouge, Nasal, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAR. Product type: Irrigator, Sinus. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAS. Product type: Knife, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAT. Product type: Perforator, Antrum. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAW. Product type: Punch, Antrum. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAX. Product type: Punch, Ethmoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAY. Product type: Punch, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KAZ. Product type: Rasp, Frontal-Sinus. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBA. Product type: Rasp, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBB. Product type: Rongeur, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBC. Product type: Saw, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBD. Product type: Scissors, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBE. Product type: Snare, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBF. Product type: Trephine, Sinus. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBG. Product type: Trocar, Sinus. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBH. Product type: Adenotome. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBI. Product type: Bougie, Eustachian. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4175. Implant flag: N. Life-sustain/support flag: N.

Official code: KBJ. Product type: Curette, Adenoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBK. Product type: Curette, Salpingeal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBL. Product type: Depressor, Metal Tongue, Surgical. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBM. Product type: Dissector, Tonsil. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBN. Product type: Gag, Mouth. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBO. Product type: Guillotine, Tonsil. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBP. Product type: Hook, Tonsil Suturing. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBQ. Product type: Knife, Tonsil. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBR. Product type: Needle, Tonsil Suturing. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBS. Product type: Punch, Adenoid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBT. Product type: Punch, Tonsil. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBW. Product type: Screw, Oral. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBX. Product type: Screw, Tonsil. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KBY. Product type: Set, Filliform, Eustachian. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4175. Implant flag: N. Life-sustain/support flag: N.

Official code: KBZ. Product type: Snare, Tonsil. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCA. Product type: Tonsillectome. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCB. Product type: Tube, Tonsil Suction. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCC. Product type: Bistoury, Tracheal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCD. Product type: Bougie, Esophageal, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCE. Product type: Cannulae, Bronchial. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: KCF. Product type: Dilator, Esophageal, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCG. Product type: Dilator, Tracheal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCH. Product type: Hook, Tracheal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCI. Product type: Trocar, Tracheal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KCJ. Product type: Applicator, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCL. Product type: Blower, Powder, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCM. Product type: Dropper, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCN. Product type: Ear Wick. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCO. Product type: Nasal Spray, Ent Delivery. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCP. Product type: Syringe, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCQ. Product type: Tube Impression And Matrix. Official classification: Class I. Official category: Dental. Regulation number: 872.6570. Implant flag: N. Life-sustain/support flag: N.

Official code: KCR. Product type: Facebow. Official classification: Class I. Official category: Dental. Regulation number: 872.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: KCS. Product type: Pantograph. Official classification: Class I. Official category: Dental. Regulation number: 872.3730. Implant flag: N. Life-sustain/support flag: N.

Official code: KCT. Product type: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6850. Implant flag: N. Life-sustain/support flag: N.

Official code: KCW. Product type: Epilator, High Frequency, Needle-Type. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: KCX. Product type: Epilator, High Frequency, Tweezer-Type. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5360. Implant flag: N. Life-sustain/support flag: N.

Official code: KCY. Product type: Tourniquet, Pneumatic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5910. Implant flag: N. Life-sustain/support flag: N.

Official code: KCZ. Product type: Prosthesis, Breast, External, Used With Adhesive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: KDA. Product type: Prosthesis, Ptfe/Carbon-Fiber. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3500. Implant flag: Y. Life-sustain/support flag: N.

Official code: KDC. Product type: Instrument, Surgical, Disposable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: KDD. Product type: Kit, Surgical Instrument, Disposable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: KDG. Product type: Chisel (Osteotome). Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: KDH. Product type: Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: KDI. Product type: Dialyzer, High Permeability With Or Without Sealed Dialysate System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5860. Implant flag: N. Life-sustain/support flag: Y.

Official code: KDJ. Product type: Set, Administration, For Peritoneal Dialysis, Disposable. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: N. Life-sustain/support flag: Y.

Official code: KDK. Product type: Container, Transport, Kidney. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: KDL. Product type: Set, Perfusion, Kidney, Disposable. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: KDM. Product type: Sigmoidoscope, Rigid, Non-Electrical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: KDN. Product type: System, Perfusion, Kidney. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: KDO. Product type: Rongeur, Cystoscopic, Hot. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: KDP. Product type: Regulator, Vacuum. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: KDQ. Product type: Bottle, Collection, Vacuum. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. Implant flag: N. Life-sustain/support flag: N.

Official code: KDT. Product type: Container, Specimen Mailer And Storage, Sterile. Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: KDW. Product type: Container, Specimen Mailer And Storage, Temperature Controlled, Sterile. Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: KDX. Product type: Solution, Decalcifier, Acid Containing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KDY. Product type: Agent, Chelating For Decalcification. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KDZ. Product type: Device, Decalcifier, Electrolytic. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEA. Product type: Resins, Ion-Exchange. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2230. Implant flag: N. Life-sustain/support flag: N.

Official code: KEE. Product type: Osmium Tetroxide. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEF. Product type: Paraformaldehyde. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEG. Product type: Lamps, Microscope. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: KEH. Product type: Micrometers, Microscope. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: KEI. Product type: Condensers, Microscope. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: KEJ. Product type: Stages, Microscope. Official classification: Class I. Official category: Pathology. Regulation number: 864.3600. Implant flag: N. Life-sustain/support flag: N.

Official code: KEL. Product type: Adhesive, Albumin-Based. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEM. Product type: Agent, Clearing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEO. Product type: Formulations, Paraffin, All. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEP. Product type: Media, Mounting, Oil Soluble. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEQ. Product type: Media, Mounting, Water Soluble. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: KER. Product type: Container, Embedding. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KES. Product type: Coverslips, Microscope Slide. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KET. Product type: Filters, Cell Collection, Tissue Processing. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEW. Product type: Slides, Microscope. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KEY. Product type: Stainer, Tissue, Automated. Official classification: Class I. Official category: Pathology. Regulation number: 864.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: KFC. Product type: Methylene Blue, Tissue Stain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KFD. Product type: Aniline Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KFE. Product type: Neutral Red. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KFF. Product type: Assay, Heparin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7525. Implant flag: N. Life-sustain/support flag: N.

Official code: KFG. Product type: Antiserum, Positive Control, Aspergillus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3040. Implant flag: N. Life-sustain/support flag: N.

Official code: KFH. Product type: Antiserum, Positive Control, Blastomyces Dermatitidis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: KFI. Product type: Strip, Virulence, Corynebacterium Diphtheriae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3140. Implant flag: N. Life-sustain/support flag: N.

Official code: KFJ. Product type: Materials, Repair Or Replacement, Pacemaker. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3710. Implant flag: Y. Life-sustain/support flag: N.

Official code: KFK. Product type: Saw, Pneumatically Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: KFL. Product type: Microtome, Sliding. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KFM. Product type: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4360. Implant flag: N. Life-sustain/support flag: N.

Official code: KFT. Product type: Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: KFW. Product type: Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: KFX. Product type: Assembly, Thigh/Knee/Shank/Ankle/Foot, External. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: KFZ. Product type: Humidifier, Non-Direct Patient Interface (Home-Use). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5460. Implant flag: N. Life-sustain/support flag: N.

Official code: KGB. Product type: Mask, Oxygen, Non-Rebreathing. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: KGC. Product type: Tube, Gastro-Enterostomy. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: KGD. Product type: Scissors For Cystoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: KGE. Product type: Forceps, Biopsy, Electric. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: KGF. Product type: Adhesive, Tissue For Aneurysmorrhaphy. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: KGG. Product type: Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: KGH. Product type: Unit, Wrist, External Limb Component, Powered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: KGI. Product type: Densitometer, Bone. Official classification: Class II. Official category: Radiology. Regulation number: 892.1170. Implant flag: N. Life-sustain/support flag: N.

Official code: KGK. Product type: Gas, Collecting Vessel. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1575. Implant flag: N. Life-sustain/support flag: N.

Official code: KGL. Product type: Cabinet, Phototherapy (Puva). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4630. Implant flag: N. Life-sustain/support flag: N.

Official code: KGM. Product type: Silicone, Liquid, Injectable. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: KGN. Product type: Wound Dressing With Animal-Derived Material(S). Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: KGO. Product type: Surgeon'S Gloves. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4460. A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Implant flag: N. Life-sustain/support flag: N.

Official code: KGQ. Product type: Cream, Gloving, Surgeon'S. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4470. Implant flag: N. Life-sustain/support flag: N.

Official code: KGS. Product type: Retention Device, Suture. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4930. Implant flag: N. Life-sustain/support flag: N.

Official code: KGT. Product type: Drape, Adhesive, Aerosol. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4380. Implant flag: N. Life-sustain/support flag: N.

Official code: KGW. Product type: Ring (Wound Protector), Drape Retention, Internal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: KGX. Product type: Tape And Bandage, Adhesive. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: KGY. Product type: Bag, Intestine. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: KGZ. Product type: Accessories, Catheter. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: KHA. Product type: Mask, Scavenging. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5590. Implant flag: N. Life-sustain/support flag: N.

Official code: KHE. Product type: Reagent, Occult Blood. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. Implant flag: N. Life-sustain/support flag: N.

Official code: KHF. Product type: Adenine Nucleotide Quantitation. Official classification: Class I. Official category: Hematology. Regulation number: 864.7040. Implant flag: N. Life-sustain/support flag: N.

Official code: KHG. Product type: Whole Blood Hemoglobin Determination. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: KHH. Product type: Stimulator, Caloric-Air. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: KHJ. Product type: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material). Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: KHL. Product type: Hearing Aid, Master. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3330. Implant flag: N. Life-sustain/support flag: N.

Official code: KHM. Product type: Nephelometric, Amylase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1070. Implant flag: N. Life-sustain/support flag: N.

Official code: KHO. Product type: Fluorometer, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2560. Implant flag: N. Life-sustain/support flag: N.

Official code: KHP. Product type: Acid, Lactic, Enzymatic Method. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1450. Implant flag: N. Life-sustain/support flag: N.

Official code: KHQ. Product type: Radioassay, Triiodothyronine Uptake. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1715. Implant flag: N. Life-sustain/support flag: N.

Official code: KHR. Product type: Absorber, Saliva, Paper. Official classification: Class I. Official category: Dental. Regulation number: 872.6050. Implant flag: N. Life-sustain/support flag: N.

Official code: KHS. Product type: Enzymatic, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: KHT. Product type: Fraction V, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5370. Implant flag: N. Life-sustain/support flag: N.

Official code: KHW. Product type: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: KHX. Product type: Platform, Force-Measuring. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.1575. Implant flag: N. Life-sustain/support flag: N.

Official code: KHY. Product type: Cane, Safety Walk. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3075. Implant flag: N. Life-sustain/support flag: N.

Official code: KIA. Product type: Cover, Cast. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6185. Implant flag: N. Life-sustain/support flag: N.

Official code: KIC. Product type: Cushion, Flotation. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: KID. Product type: Restraint, Wheelchair, Non-Protective. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: KIE. Product type: Apparatus, High Pressure Liquid Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: KIF. Product type: Resin, Root Canal Filling. Official classification: Class II. Official category: Dental. Regulation number: 872.3820. Implant flag: N. Life-sustain/support flag: N.

Official code: KIG. Product type: Prosthesis, Wrist, Constrained, Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3780. Implant flag: Y. Life-sustain/support flag: N.

Official code: KIH. Product type: Dispenser, Cement. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: KII. Product type: Tube, Cement Ventilation. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4230. Implant flag: N. Life-sustain/support flag: N.

Official code: KIJ. Product type: Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: KIK. Product type: Hook, Bone. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: KIL. Product type: Positioner, Socket. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: KIM. Product type: Device For Sealing Microsections. Official classification: Class I. Official category: Pathology. Regulation number: 864.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: KIN. Product type: Slide Stainer, Contact Type. Official classification: Class I. Official category: Pathology. Regulation number: 864.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: KIO. Product type: Slide Stainer, Immersion Type. Official classification: Class I. Official category: Pathology. Regulation number: 864.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: KIP. Product type: Formulations, Balanced Salt Solutions. Official classification: Class I. Official category: Hematology. Regulation number: 864.2875. Implant flag: N. Life-sustain/support flag: N.

Official code: KIQ. Product type: Kit, Culture, Chromosome. Official classification: Class I. Official category: Hematology. Regulation number: 864.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: KIR. Product type: Cells, Animal And Human, Cultured. Official classification: Class I. Official category: Hematology. Regulation number: 864.2280. Implant flag: N. Life-sustain/support flag: N.

Official code: KIS. Product type: Sera, Animal And Human. Official classification: Class I. Official category: Hematology. Regulation number: 864.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: KIT. Product type: Media And Components, Synthetic Cell And Tissue Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2220. Implant flag: N. Life-sustain/support flag: N.

Official code: KIW. Product type: Kit, Mycoplasma Detection. Official classification: Class I. Official category: Hematology. Regulation number: 864.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: KIX. Product type: Media, Mycoplasma Detection. Official classification: Class I. Official category: Hematology. Regulation number: 864.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: KIY. Product type: Chamber, Slide Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KIZ. Product type: Dish, Tissue Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJA. Product type: Flask, Tissue Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJB. Product type: Apparatus, Roller. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJC. Product type: Bottle, Roller, Tissue Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJD. Product type: Spinner, Flask. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJE. Product type: Spinner System, Cell Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJF. Product type: System, Suspension, Cell Culture. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJG. Product type: Tube, Tissue Culture. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: KJH. Product type: Apparatus, Perfusion. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Implant flag: N. Life-sustain/support flag: N.

Official code: KJI. Product type: Radioimmunoassay, Kanamycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: KJJ. Product type: Cleanser, Root Canal. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: KJK. Product type: Auramine O. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJL. Product type: Azure C. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJM. Product type: Bismarck Brown Y. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJN. Product type: Brilliant Cresyl Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJO. Product type: Brilliant Green. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJP. Product type: Carmine. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJQ. Product type: Chlorazol Black E. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJR. Product type: Erythrosin B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJS. Product type: Ethyl Eosin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJT. Product type: Indigocarmine. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJW. Product type: Janus Green B. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJX. Product type: Jenner Stain. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJY. Product type: Malachite Green. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KJZ. Product type: Martius Yellow. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKA. Product type: Methyl Orange. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKB. Product type: Methyl Violet 2b. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKC. Product type: Methylene Violet. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKD. Product type: Nigrosin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKE. Product type: Orange Ii. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKF. Product type: Orcein. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKG. Product type: Protargol S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKH. Product type: Tablet, Resazurin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKI. Product type: Rose Bengal. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKJ. Product type: Sudan Iii. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKK. Product type: Sudan Iv. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKL. Product type: Thionin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKM. Product type: Methylene Blue Thiocyanate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKO. Product type: Ring, Teething, Fluid-Filled. Official classification: Class II. Official category: Dental. Regulation number: 872.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: KKP. Product type: Solution, Silver Carbonate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKQ. Product type: Sodium Periodate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKR. Product type: Potassium Periodate. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKS. Product type: Acid, Periodic. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKT. Product type: Hematoxylin, Ehrlich'S. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKW. Product type: Basic Fuchsin. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KKX. Product type: Drape, Surgical, Antimicrobial. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI. Implant flag: N. Life-sustain/support flag: N.

Official code: KKY. Product type: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3500. Implant flag: Y. Life-sustain/support flag: N.

Official code: KLA. Product type: Monitor, Esophageal Motility, Anorectal Motility, And Tube. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1725. Implant flag: N. Life-sustain/support flag: N.

Official code: KLB. Product type: Radioimmunoassay, Tobramycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: KLC. Product type: Chair, Dental, With Operative Unit. Official classification: Class I. Official category: Dental. Regulation number: 872.6250. Implant flag: N. Life-sustain/support flag: N.

Official code: KLE. Product type: Agent, Tooth Bonding, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: KLH. Product type: Antisera, C. Acnes. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3140. Implant flag: N. Life-sustain/support flag: N.

Official code: KLI. Product type: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: KLJ. Product type: Nad Reduction (U.V.), Phosphohexose Isomerase. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: KLK. Product type: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2500. Implant flag: N. Life-sustain/support flag: N.

Official code: KLN. Product type: Radioimmunoassay, Cocaine Metabolite. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: KLO. Product type: Enzymatic Radiochemical Assay, Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: KLP. Product type: Amikacin Serum Assay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3035. Implant flag: N. Life-sustain/support flag: N.

Official code: KLQ. Product type: Radioimmunoassay, Amikacin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3035. Implant flag: N. Life-sustain/support flag: N.

Official code: KLR. Product type: Enzyme Immunoassay, Lidocaine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3555. Implant flag: N. Life-sustain/support flag: N.

Official code: KLS. Product type: Enzyme Immunoassay, Theophylline. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: KLT. Product type: Enzyme Immunoassay, Carbamazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: KLW. Product type: Masker, Tinnitus. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: KLX. Product type: Electroglottograph. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1325. Implant flag: N. Life-sustain/support flag: N.

Official code: KLZ. Product type: Tube, Shunt, Endolymphatic With Valve. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3850. Implant flag: Y. Life-sustain/support flag: N.

Official code: KMA. Product type: Irrigator, Powered Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: KMB. Product type: Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3490. Implant flag: Y. Life-sustain/support flag: N.

Official code: KMC. Product type: Prosthesis, Hip, Semi-Constrained, Composite/Metal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3340. Implant flag: Y. Life-sustain/support flag: N.

Official code: KMD. Product type: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3100. Implant flag: Y. Life-sustain/support flag: N.

Official code: KME. Product type: Bedding, Disposable, Medical. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6060. Implant flag: N. Life-sustain/support flag: N.

Official code: KMF. Product type: Bandage, Liquid. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: KMG. Product type: Purifier, Water, Ultraviolet, Medical. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6710. Implant flag: N. Life-sustain/support flag: N.

Official code: KMH. Product type: Sterilizer, Dry Heat. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6870. Implant flag: N. Life-sustain/support flag: N.

Official code: KMI. Product type: Monitor, Bed Patient. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2400. Implant flag: N. Life-sustain/support flag: N.

Official code: KMJ. Product type: Lubricant, Patient. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6375. Implant flag: N. Life-sustain/support flag: N.

Official code: KMK. Product type: Device, Intravascular Catheter Securement. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5210. Implant flag: N. Life-sustain/support flag: N.

Official code: KMN. Product type: Chair And Table, Medical. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6140. Implant flag: N. Life-sustain/support flag: N.

Official code: KMO. Product type: Binder, Elastic. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: KMS. Product type: Phenolphthalein Colorimetry, Carbon-Dioxide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: KMT. Product type: Tray, Fluoride, Disposable. Official classification: Class I. Official category: Dental. Regulation number: 872.6870. Implant flag: N. Life-sustain/support flag: N.

Official code: KMW. Product type: Handpiece, Rotary Bone Cutting. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. Implant flag: N. Life-sustain/support flag: N.

Official code: KMY. Product type: Positioner, Tooth, Preformed. Official classification: Class I. Official category: Dental. Regulation number: 872.5525. Implant flag: N. Life-sustain/support flag: N.

Official code: KNA. Product type: Instrument, Manual, Specialized Obstetric-Gynecologic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: KNB. Product type: Instrument, Destructive, Fetal, Obstetric. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: KNC. Product type: Table, Obstetric (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4900. Implant flag: N. Life-sustain/support flag: N.

Official code: KND. Product type: Heater, Perineal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5390. Implant flag: N. Life-sustain/support flag: N.

Official code: KNE. Product type: Set, Anesthesia, Obstetric. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: KNF. Product type: Coagulator-Cutter, Endoscopic, Unipolar (And Accessories). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: KNG. Product type: Monitor, Ultrasonic, Fetal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: KNH. Product type: Laparoscopic Contraceptive Tubal Occlusion Device. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5380. Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87)) Implant flag: Y. Life-sustain/support flag: N.

Official code: KNK. Product type: Acid, Uric, Uricase (Colorimetric). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. Implant flag: N. Life-sustain/support flag: N.

Official code: KNL. Product type: Board, Scooter, Prone. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5370. Implant flag: N. Life-sustain/support flag: N.

Official code: KNM. Product type: Device, Pressure Applying. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5765. Implant flag: N. Life-sustain/support flag: N.

Official code: KNN. Product type: Components, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: KNO. Product type: Accessories, Wheelchair. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: KNP. Product type: Orthosis, Corrective Shoe. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: KNQ. Product type: Dilator, Esophageal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5365. Implant flag: N. Life-sustain/support flag: N.

Official code: KNR. Product type: Adapter, A-V Shunt Or Fistula. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: KNS. Product type: Unit, Electrosurgical, Endoscopic (With Or Without Accessories). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: KNT. Product type: Tubes, Gastrointestinal (And Accessories). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: KNW. Product type: Instrument, Biopsy. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Implant flag: N. Life-sustain/support flag: N.

Official code: KNX. Product type: Collector, Urine, (And Accessories) For Indwelling Catheter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: KNY. Product type: Accessories, Catheter, G-U. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: KNZ. Product type: Accessories, A-V Shunt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: KOA. Product type: Surgical Instruments, G-U, Manual (And Accessories). Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: KOB. Product type: Catheter, Suprapubic (And Accessories). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5090. Implant flag: Y. Life-sustain/support flag: N.

Official code: KOC. Product type: Accessories, Blood Circuit, Hemodialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: KOD. Product type: Catheter, Urological. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: KOE. Product type: Dilator, Urethral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5520. Implant flag: N. Life-sustain/support flag: N.

Official code: KOH. Product type: Instrument, Manual, General Obstetric-Gynecologic. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. Implant flag: N. Life-sustain/support flag: N.

Official code: KOI. Product type: Stimulator, Nerve, Peripheral, Electric. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2775. Implant flag: N. Life-sustain/support flag: N.

Official code: KOJ. Product type: Airbrush. Official classification: Class II. Official category: Dental. Regulation number: 872.6080. Implant flag: N. Life-sustain/support flag: N.

Official code: KOK. Product type: Sterilizer, Endodontic Dry Heat. Official classification: Class III. Official category: Dental. Regulation number: 872.6730. Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97 Implant flag: N. Life-sustain/support flag: N.

Official code: KOL. Product type: Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer. Official classification: Class I. Official category: Dental. Regulation number: 872.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: KOM. Product type: Adhesive, Denture, Acacia And Karaya With Sodium Borate. Official classification: Class I. Official category: Dental. Regulation number: 872.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: KON. Product type: Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic). Official classification: Class III. Official category: Dental. Regulation number: 872.3480. Call for PMAs 12/26/96 per 61 FR 50707 on 9/26/96 Implant flag: N. Life-sustain/support flag: N.

Official code: KOO. Product type: Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt. Official classification: Class I. Official category: Dental. Regulation number: 872.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: KOP. Product type: Adhesive, Denture, Karaya. Official classification: Class I. Official category: Dental. Regulation number: 872.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: KOQ. Product type: Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&). Official classification: Class I. Official category: Dental. Regulation number: 872.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: KOR. Product type: Adhesive, Denture, Karaya With Sodium Borate. Official classification: Class III. Official category: Dental. Regulation number: 872.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: KOS. Product type: Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer. Official classification: Class III. Official category: Dental. Regulation number: 872.3420. Implant flag: N. Life-sustain/support flag: N.

Official code: KOT. Product type: Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium. Official classification: Class I. Official category: Dental. Regulation number: 872.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: KOX. Product type: Solvent, Adhesive Tape. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: KOY. Product type: Degreaser, Skin, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4730. Implant flag: N. Life-sustain/support flag: N.

Official code: KOZ. Product type: Beads, Hydrophilic, For Wound Exudate Absorption. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4018. Implant flag: N. Life-sustain/support flag: N.

Official code: KPA. Product type: Slide Stainer, Automated. Official classification: Class I. Official category: Pathology. Regulation number: 864.3800. Implant flag: N. Life-sustain/support flag: N.

Official code: KPB. Product type: Media And Components, Mycoplasma Detection. Official classification: Class I. Official category: Hematology. Regulation number: 864.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: KPD. Product type: Strip, Temperature, Forehead, Liquid Crystal. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2200. Implant flag: N. Life-sustain/support flag: N.

Official code: KPE. Product type: Container, I.V.. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5025. Implant flag: N. Life-sustain/support flag: N.

Official code: KPF. Product type: System, Dialysate Delivery, Semi-Automatic, Peritoneal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: N. Life-sustain/support flag: Y.

Official code: KPH. Product type: Catheter, Rectal For Continent Ileostomy. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5030. Implant flag: N. Life-sustain/support flag: N.

Official code: KPI. Product type: Stimulator, Electrical, Non-Implantable, For Incontinence. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5320. Implant flag: N. Life-sustain/support flag: N.

Official code: KPJ. Product type: Chamber, Oxygen, Topical, Extremity. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5650. Implant flag: N. Life-sustain/support flag: N.

Official code: KPK. Product type: Marker, Ostia, Aorto-Saphenous Vein. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4650. Implant flag: Y. Life-sustain/support flag: N.

Official code: KPL. Product type: Colonic Irrigation System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: KPM. Product type: Shunt, Peritoneal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5955. Implant flag: Y. Life-sustain/support flag: N.

Official code: KPN. Product type: Alarm, Conditioned Response Enuresis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.2040. Implant flag: N. Life-sustain/support flag: N.

Official code: KPO. Product type: Dialysate Concentrate For Hemodialysis (Liquid Or Powder). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: KPP. Product type: Peritoneal Dialysate Filter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: N. Life-sustain/support flag: Y.

Official code: KPQ. Product type: System, Simulation, Radiation Therapy. Official classification: Class II. Official category: Radiology. Regulation number: 892.5840. Implant flag: N. Life-sustain/support flag: N.

Official code: KPR. Product type: System, X-Ray, Stationary. Official classification: Class II. Official category: Radiology. Regulation number: 892.1680. Implant flag: N. Life-sustain/support flag: N.

Official code: KPS. Product type: System, Tomography, Computed, Emission. Official classification: Class II. Official category: Radiology. Regulation number: 892.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: KPT. Product type: Calibrator, Dose, Radionuclide. Official classification: Class II. Official category: Radiology. Regulation number: 892.1360. Implant flag: N. Life-sustain/support flag: N.

Official code: KPW. Product type: Device, Beam Limiting, X-Ray, Diagnostic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1610. Implant flag: N. Life-sustain/support flag: N.

Official code: KPX. Product type: Changer, Radiographic Film/Cassette. Official classification: Class II. Official category: Radiology. Regulation number: 892.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: KPY. Product type: Shield, Protective, Personnel. Official classification: Class I. Official category: Radiology. Regulation number: 892.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: KPZ. Product type: Generator, High Voltage, X-Ray, Therapeutic. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: KQA. Product type: Device, Beam Limiting, X-Ray, Therapeutic. Official classification: Class II. Official category: Radiology. Regulation number: 892.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: KQC. Product type: Stains, Hematology. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: KQE. Product type: Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase. Official classification: Class II. Official category: Hematology. Regulation number: 864.7360. Implant flag: N. Life-sustain/support flag: N.

Official code: KQF. Product type: Assay, Glutathione Reductase. Official classification: Class II. Official category: Hematology. Regulation number: 864.7375. Implant flag: N. Life-sustain/support flag: N.

Official code: KQG. Product type: Instrument, Coagulation. Official classification: Class II. Official category: Hematology. Regulation number: 864.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: KQH. Product type: Red-Cell Indices. Official classification: Class II. Official category: Hematology. Regulation number: 864.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: KQI. Product type: Assay, Fetal Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7455. Implant flag: N. Life-sustain/support flag: N.

Official code: KQJ. Product type: System, Fibrinogen Determination. Official classification: Class II. Official category: Hematology. Regulation number: 864.7340. Implant flag: N. Life-sustain/support flag: N.

Official code: KQL. Product type: Tube, Tympanostomy With Semi-Permeable Membrane. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3930. Implant flag: Y. Life-sustain/support flag: N.

Official code: KQM. Product type: Camera, Surgical And Accessories. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. Implant flag: N. Life-sustain/support flag: N.

Official code: KQN. Product type: Radioassay, Angiotensin Converting Enzyme. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1090. Implant flag: N. Life-sustain/support flag: N.

Official code: KQO. Product type: Automated Urinalysis System. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: KQP. Product type: Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1315. Implant flag: N. Life-sustain/support flag: N.

Official code: KQQ. Product type: Tubing, Dialysate (And Connector). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: KQR. Product type: Detector, Air Or Foam. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: KQS. Product type: Table, Cystometric, Non-Electric And Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4890. Implant flag: N. Life-sustain/support flag: N.

Official code: KQT. Product type: Evacuator, Gastro-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: KQW. Product type: Goniometer, Nonpowered. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.1520. Implant flag: N. Life-sustain/support flag: N.

Official code: KQX. Product type: Goniometer, Ac-Powered. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: KQZ. Product type: Component, Traction, Non-Invasive. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: KRA. Product type: Catheter, Continuous Flush. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1210. Implant flag: N. Life-sustain/support flag: N.

Official code: KRB. Product type: Probe, Thermodilution. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1915. Implant flag: N. Life-sustain/support flag: N.

Official code: KRC. Product type: Tester, Electrode, Surface, Electrocardiographic. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2370. Implant flag: N. Life-sustain/support flag: N.

Official code: KRD. Product type: Device, Vascular, For Promoting Embolization. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: KRE. Product type: Analyzer, Pacemaker Generator Function, Indirect. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: KRF. Product type: Charger, Pacemaker. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3670. Implant flag: N. Life-sustain/support flag: N.

Official code: KRG. Product type: Programmer, Pacemaker. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: KRH. Product type: Ring, Annuloplasty. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3800. Implant flag: Y. Life-sustain/support flag: N.

Official code: KRI. Product type: Accessory Equipment, Cardiopulmonary Bypass. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.4200. Implant flag: N. Life-sustain/support flag: N.

Official code: KRJ. Product type: Filter, Prebypass, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4280. Implant flag: N. Life-sustain/support flag: N.

Official code: KRK. Product type: Manometer, Blood-Pressure, Venous. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1140. Implant flag: N. Life-sustain/support flag: N.

Official code: KRL. Product type: Detector, Bubble, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4205. Implant flag: N. Life-sustain/support flag: N.

Official code: KRN. Product type: Metal Cemented Constrained Femorotibial Knee Prosthesis. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3480. Call for pmas 12/26/96 ( 61 fr 50710 9/27/96) Implant flag: Y. Life-sustain/support flag: N.

Official code: KRO. Product type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3510. Implant flag: Y. Life-sustain/support flag: N.

Official code: KRP. Product type: Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3550. Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KRQ. Product type: Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3550. Implant flag: Y. Life-sustain/support flag: N.

Official code: KRR. Product type: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3540. Implant flag: Y. Life-sustain/support flag: N.

Official code: KRS. Product type: Prosthesis, Knee, Hemi-, Femoral (Uncemented). Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3570. Implant flag: Y. Life-sustain/support flag: N.

Official code: KRX. Product type: Calibrator For Cell Indices. Official classification: Class II. Official category: Hematology. Regulation number: 864.8150. Implant flag: N. Life-sustain/support flag: N.

Official code: KRY. Product type: Calibrator For Platelet Counting. Official classification: Class II. Official category: Hematology. Regulation number: 864.8175. Implant flag: N. Life-sustain/support flag: N.

Official code: KRZ. Product type: Calibrator For Hemoglobin And Hematocrit Measurement. Official classification: Class II. Official category: Hematology. Regulation number: 864.8165. Implant flag: N. Life-sustain/support flag: N.

Official code: KSA. Product type: Calibrator For Red-Cell And White-Cell Counting. Official classification: Class II. Official category: Hematology. Regulation number: 864.8185. Implant flag: N. Life-sustain/support flag: N.

Official code: KSB. Product type: Set, Transfer (Blood/Plasma). Official classification: Class II. Official category: Hematology. Regulation number: 864.9875. Implant flag: N. Life-sustain/support flag: N.

Official code: KSD. Product type: Device, Heat-Sealing. Official classification: Class I. Official category: Hematology. Regulation number: 864.9750. Implant flag: N. Life-sustain/support flag: N.

Official code: KSE. Product type: Refrigerator, Freezer, Blood Storage. Official classification: Class II. Official category: Hematology. Regulation number: 864.9700. Implant flag: N. Life-sustain/support flag: N.

Official code: KSF. Product type: Kit, Quality Control For Blood Banking Reagents. Official classification: Class II. Official category: Hematology. Regulation number: 864.9650. Implant flag: N. Life-sustain/support flag: N.

Official code: KSG. Product type: Media, Potentiating For In Vitro Diagnostic Use. Official classification: Class II. Official category: Hematology. Regulation number: 864.9600. Implant flag: N. Life-sustain/support flag: N.

Official code: KSH. Product type: Chamber, Environmental For The Storage Of Platelet Concentrate. Official classification: Class II. Official category: Hematology. Regulation number: 864.9575. Implant flag: N. Life-sustain/support flag: N.

Official code: KSI. Product type: Lectins And Protectins. Official classification: Class II. Official category: Hematology. Regulation number: 864.9550. Implant flag: N. Life-sustain/support flag: N.

Official code: KSJ. Product type: System, Identification, Hepatitis B Antigen. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: KSK. Product type: Solution, Stabilized Enzyme. Official classification: Class II. Official category: Hematology. Regulation number: 864.9400. Implant flag: N. Life-sustain/support flag: N.

Official code: KSL. Product type: Solution, Copper Sulfate For Specific Gravity Determinations. Official classification: Class I. Official category: Hematology. Regulation number: 864.9320. Implant flag: N. Life-sustain/support flag: N.

Official code: KSM. Product type: System, Test, Combs, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.9300. Implant flag: N. Life-sustain/support flag: N.

Official code: KSN. Product type: Centrifuge, Cell-Washing, Automated For Immuno-Hematology. Official classification: Class II. Official category: Hematology. Regulation number: 864.9285. Implant flag: N. Life-sustain/support flag: N.

Official code: KSO. Product type: Centrifuge, Blood-Bank For In Vitro Diagnostic Use. Official classification: Class I. Official category: Hematology. Regulation number: 864.9275. Implant flag: N. Life-sustain/support flag: N.

Official code: KSP. Product type: Apparatus, Cell-Freezing And Reagents. Official classification: Class I. Official category: Hematology. Regulation number: 864.9225. Implant flag: N. Life-sustain/support flag: N.

Official code: KSQ. Product type: Device, Blood Mixing And Blood Weighing. Official classification: Class I. Official category: Hematology. Regulation number: 864.9195. Implant flag: N. Life-sustain/support flag: N.

Official code: KSR. Product type: Container, Empty, For Collection & Processing Of Blood & Blood Components. Official classification: Class II. Official category: Hematology. Regulation number: 864.9100. Implant flag: N. Life-sustain/support flag: N.

Official code: KSS. Product type: Supplies, Blood-Bank. Official classification: Class I. Official category: Hematology. Regulation number: 864.9050. Implant flag: N. Life-sustain/support flag: N.

Official code: KST. Product type: System, Blood Collection, Vacuum-Assisted, Manual. Official classification: Class I. Official category: Hematology. Regulation number: 864.9125. Implant flag: N. Life-sustain/support flag: N.

Official code: KSW. Product type: System, Processing For Frozen Blood. Official classification: Class II. Official category: Hematology. Regulation number: 864.9145. Implant flag: N. Life-sustain/support flag: N.

Official code: KSX. Product type: Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use. Official classification: Class II. Official category: Hematology. Regulation number: 864.9160. Implant flag: N. Life-sustain/support flag: N.

Official code: KSY. Product type: Boxes, View, Blood Grouping. Official classification: Class I. Official category: Hematology. Regulation number: 864.9185. Implant flag: N. Life-sustain/support flag: N.

Official code: KSZ. Product type: System, Test, Automated Blood Grouping And Antibody. Official classification: Class II. Official category: Hematology. Regulation number: 864.9175. Implant flag: N. Life-sustain/support flag: N.

Official code: KTA. Product type: Medium, Contrast, Radiologic. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: KTB. Product type: Device, Iontophoresis, Specific Uses. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5525. Implant flag: N. Life-sustain/support flag: N.

Official code: KTC. Product type: Bath, Sitz, Nonpowered. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5125. Implant flag: N. Life-sustain/support flag: N.

Official code: KTD. Product type: Orthosis, Abdominal. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: KTE. Product type: Trocar, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KTF. Product type: Punch, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KTG. Product type: Knife, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: KTH. Product type: Device, Anti-Stammering. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5840. Implant flag: N. Life-sustain/support flag: N.

Official code: KTI. Product type: Bronchoscope Accessory. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: KTJ. Product type: System, Test, Alpha-Fetoprotein, Ria. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: KTK. Product type: Reagent, Immunoassay, Carbonic Anhydrase B And C. Official classification: Class I. Official category: Immunology. Regulation number: 866.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: KTL. Product type: Anti-Dna Indirect Immunofluorescent Solid Phase. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: KTM. Product type: C3-Indirect Immunofluorescent Solid Phase. Official classification: Class II. Official category: Immunology. Regulation number: 866.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: KTN. Product type: System, Test, Infectious Mononucleosis. Official classification: Class II. Official category: Immunology. Regulation number: 866.5640. Implant flag: N. Life-sustain/support flag: N.

Official code: KTO. Product type: Reagent, Immunoassay, Igg. Official classification: Class I. Official category: Immunology. Regulation number: 866.5530. Implant flag: N. Life-sustain/support flag: N.

Official code: KTP. Product type: Complement C3b Activator Immunoassay Reagents. Official classification: Class II. Official category: Immunology. Regulation number: 866.5260. Implant flag: N. Life-sustain/support flag: N.

Official code: KTQ. Product type: Reagent, Complement. Official classification: Class I. Official category: Immunology. Regulation number: 866.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: KTR. Product type: Tube, Aspirating, Bronchoscope, Rigid. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: KTS. Product type: Second Antibody (Species Specific Anti-Animal Gamma Globulin). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: KTT. Product type: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: KTW. Product type: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: KTX. Product type: Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3490. Implant flag: Y. Life-sustain/support flag: N.

Official code: KTZ. Product type: Caliper. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: KWA. Product type: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3330. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWB. Product type: Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3370. Call for PMAs 12/26/96 (61 FR 50710 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: KWD. Product type: Prosthesis, Toe, Hemi-, Phalangeal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3730. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWE. Product type: Prosthesis, Finger, Constrained, Metal, Uncemented. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3200. call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KWF. Product type: Prosthesis, Finger, Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3230. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWG. Product type: Prosthesis, Finger, Constrained, Metal/Polymer. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3220. Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KWH. Product type: Prosthesis, Toe, Constrained, Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3720. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWI. Product type: Prosthesis, Elbow, Hemi-, Radial, Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3170. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWJ. Product type: Prosthesis, Elbow, Hemi-, Humeral, Metal. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3180. call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KWK. Product type: Appliance, Nail/Blade/Plate Combination, Single Component. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWL. Product type: Prosthesis, Hip, Hemi-, Femoral, Metal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3360. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWM. Product type: Prosthesis, Wrist, Semi-Constrained. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3800. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWN. Product type: Prosthesis, Wrist, Carpal Lunate. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3750. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWO. Product type: Prosthesis, Wrist, Carpal Scaphoid. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3760. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWP. Product type: Appliance, Fixation, Spinal Interlaminal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3050. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWQ. Product type: Appliance, Fixation, Spinal Intervertebral Body. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWR. Product type: Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3640. Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KWS. Product type: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3660. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWT. Product type: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3650. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWW. Product type: Radioimmunoassay, Cholyglycine, Bile Acids. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1177. Implant flag: N. Life-sustain/support flag: N.

Official code: KWX. Product type: Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1187. Implant flag: N. Life-sustain/support flag: N.

Official code: KWY. Product type: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3390. Implant flag: Y. Life-sustain/support flag: N.

Official code: KWZ. Product type: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3310. Implant flag: Y. Life-sustain/support flag: N.

Official code: KXA. Product type: Prosthesis, Hip, Femoral, Resurfacing. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3400. Implant flag: Y. Life-sustain/support flag: N.

Official code: KXB. Product type: Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3410. Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution. Implant flag: Y. Life-sustain/support flag: N.

Official code: KXC. Product type: Prosthesis, Ankle, Cemented, Non-Constrained. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3120. Implant flag: Y. Life-sustain/support flag: N.

Official code: KXD. Product type: Prosthesis, Hip, Constrained, Metal. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3300. Call for PMAs 12/26/96 (61 FR 50709 (9/27/96)) Implant flag: Y. Life-sustain/support flag: N.

Official code: KXE. Product type: Prosthesis, Wrist, Hemi-, Ulnar. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3810. Implant flag: Y. Life-sustain/support flag: N.

Official code: KXF. Product type: Applicator, Absorbent Tipped, Non-Sterile. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6025. Implant flag: N. Life-sustain/support flag: N.

Official code: KXG. Product type: Applicator, Absorbent Tipped, Sterile. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6025. Implant flag: N. Life-sustain/support flag: N.

Official code: KXH. Product type: Cradle, Patient, Radiologic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1830. Implant flag: N. Life-sustain/support flag: N.

Official code: KXJ. Product type: Table, Radiologic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1980. Implant flag: N. Life-sustain/support flag: N.

Official code: KXK. Product type: Source, Brachytherapy, Radionuclide. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. Implant flag: Y. Life-sustain/support flag: N.

Official code: KXM. Product type: System Accessories, Extracorporeal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: KXN. Product type: Monitor, Cardiac, Fetal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2600. Implant flag: N. Life-sustain/support flag: N.

Official code: KXO. Product type: Monitor, Pressure, Intrauterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: KXP. Product type: Stent, Vaginal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: KXQ. Product type: Vibrator For Therapeutic Use, Genital. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5960. Implant flag: N. Life-sustain/support flag: N.

Official code: KXR. Product type: Applicator, Resin. Official classification: Class I. Official category: Dental. Regulation number: 872.3140. Implant flag: N. Life-sustain/support flag: N.

Official code: KXS. Product type: Radioimmunoassay, Methaqualone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3630. Implant flag: N. Life-sustain/support flag: N.

Official code: KXT. Product type: Enzyme Immunoassay, Digoxin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: KXW. Product type: Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer. Official classification: Class I. Official category: Dental. Regulation number: 872.3410. Implant flag: N. Life-sustain/support flag: N.

Official code: KXX. Product type: Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer. Official classification: Class I. Official category: Dental. Regulation number: 872.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: KXY. Product type: Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce. Official classification: Class III. Official category: Dental. Regulation number: 872.3500. Call for PMAs 12/26/96 per 61 FR 50707 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: KXZ. Product type: System, Thermographic, Liquid Crystal, Powered (Adjunctive Use). Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2982. Implant flag: N. Life-sustain/support flag: N.

Official code: KYA. Product type: System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use). Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.2982. Implant flag: N. Life-sustain/support flag: N.

Official code: KYB. Product type: Lens, Guide, Intraocular. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: KYD. Product type: Strip, Schirmer. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: KYE. Product type: Inserter/Remover Contact Lens. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: KYF. Product type: Implant, Eye Valve. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3920. Implant flag: Y. Life-sustain/support flag: N.

Official code: KYG. Product type: Device, Irrigation, Ocular Surgery. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4360. Implant flag: N. Life-sustain/support flag: N.

Official code: KYH. Product type: Endoscope, Ophthalmic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: KYI. Product type: Prosthesis, Wrist, Carpal Trapezium. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3770. Implant flag: Y. Life-sustain/support flag: N.

Official code: KYJ. Product type: Prosthesis, Finger, Constrained, Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3230. Implant flag: Y. Life-sustain/support flag: N.

Official code: KYK. Product type: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3500. Implant flag: Y. Life-sustain/support flag: N.

Official code: KYM. Product type: Metallic Cemented Glenoid Hemi-Shoulder Prosthesis. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3680. Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KYN. Product type: Prosthesis, Wrist, Constrained, Metal. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3790. Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: KYP. Product type: Snake Bite Suction Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5740. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: KYQ. Product type: Kit, Chemical Snake-Bite. Official classification: Class III. Official category: General Hospital. Regulation number: 880.5760. Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 Implant flag: N. Life-sustain/support flag: N.

Official code: KYR. Product type: Bag, Ice. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6050. Implant flag: N. Life-sustain/support flag: N.

Official code: KYS. Product type: Insoles, Medical. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6280. Implant flag: N. Life-sustain/support flag: N.

Official code: KYT. Product type: Light, Examination, Medical, Battery Powered. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6350. Implant flag: N. Life-sustain/support flag: N.

Official code: KYW. Product type: Container, Liquid Medication, Graduated. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6430. Implant flag: N. Life-sustain/support flag: N.

Official code: KYX. Product type: Dispenser, Liquid Medication. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6430. Implant flag: N. Life-sustain/support flag: N.

Official code: KYZ. Product type: Syringe, Irrigating (Non Dental). Official classification: Class I. Official category: General Hospital. Regulation number: 880.6960. Implant flag: N. Life-sustain/support flag: N.

Official code: KZA. Product type: Device, Vein Location, Liquid Crystal. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6970. Implant flag: N. Life-sustain/support flag: N.

Official code: KZB. Product type: Automated Colony Counter. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2170. Implant flag: N. Life-sustain/support flag: N.

Official code: KZC. Product type: Manual Colony Counter. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2180. Implant flag: N. Life-sustain/support flag: N.

Official code: KZD. Product type: Infusor, Pressure, For I.V. Bags. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: KZE. Product type: Injector, Fluid, Non-Electrically Powered. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5430. Implant flag: N. Life-sustain/support flag: N.

Official code: KZF. Product type: Device, Medical Examination, Ac Powered. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6320. Implant flag: N. Life-sustain/support flag: N.

Official code: KZH. Product type: Introducer, Syringe Needle. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6920. Implant flag: N. Life-sustain/support flag: N.

Official code: KZI. Product type: Culture Media, Enriched. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2330. Implant flag: N. Life-sustain/support flag: N.

Official code: KZJ. Product type: Device, Gas Generating. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2580. Implant flag: N. Life-sustain/support flag: N.

Official code: KZK. Product type: Reader, Zone, Automated. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2850. Implant flag: N. Life-sustain/support flag: N.

Official code: KZL. Product type: Device, Warming. Blood And Plasma. Official classification: Class II. Official category: Hematology. Regulation number: 864.9205. Implant flag: N. Life-sustain/support flag: N.

Official code: KZM. Product type: Device, Muscle Monitoring. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1375. Implant flag: N. Life-sustain/support flag: N.

Official code: KZN. Product type: Scanner, Color. Official classification: Class II. Official category: Dental. Regulation number: 872.3661. Implant flag: N. Life-sustain/support flag: N.

Official code: KZO. Product type: Ink, Arch Tracing. Official classification: Class I. Official category: Dental. Regulation number: 872.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: KZP. Product type: Solution, Cement Dissolving. Official classification: Class II. Official category: Dental. Regulation number: 872.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: KZQ. Product type: Chromatography(Gas), Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2250. Implant flag: N. Life-sustain/support flag: N.

Official code: KZR. Product type: Chromatography (Liquid, Gel), Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: KZS. Product type: Chromatography (Thin Layer), Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2270. Implant flag: N. Life-sustain/support flag: N.

Official code: KZT. Product type: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: KZW. Product type: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3520. Implant flag: N. Life-sustain/support flag: N.

Official code: KZX. Product type: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: KZY. Product type: High Pressure Liquid Chromatography, Barbiturate. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. Implant flag: N. Life-sustain/support flag: N.

Official code: KZZ. Product type: Gas Chromatography, Benzodiazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3170. Implant flag: N. Life-sustain/support flag: N.

Official code: LAA. Product type: High Pressure Liquid Chromatography, Benzodiazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3170. Implant flag: N. Life-sustain/support flag: N.

Official code: LAB. Product type: Thin Layer Chromatography, Benzodiazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3170. Implant flag: N. Life-sustain/support flag: N.

Official code: LAC. Product type: High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: LAD. Product type: Gas Chromatography, Codeine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3270. Implant flag: N. Life-sustain/support flag: N.

Official code: LAE. Product type: High Pressure Liquid Chromatography, Codeine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3270. Implant flag: N. Life-sustain/support flag: N.

Official code: LAF. Product type: Gas Chromatography, Methamphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3610. Implant flag: N. Life-sustain/support flag: N.

Official code: LAG. Product type: High Pressure Liquid Chromatography, Methamphetamine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3610. Implant flag: N. Life-sustain/support flag: N.

Official code: LAH. Product type: High Pressure Liquid Chromatography, Opiates. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: LAI. Product type: Thin Layer Chromatography, Opiates. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: LAJ. Product type: Gas Chromatography, Propoxyphene. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: LAK. Product type: High Pressure Liquid Chromatography, Propoxyphene. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: LAL. Product type: Eas Chromatography, Quinine. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: LAM. Product type: High Pressure Liquid Chromatography, Quinine. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3750. Implant flag: N. Life-sustain/support flag: N.

Official code: LAN. Product type: Enzyme Immunoassay, N-Acetylprocainamide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: LAO. Product type: Enzyme Immunoassay, Methotrexate. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LAR. Product type: Enzyme Immunoassay, Procainamide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: LAS. Product type: Drug Specific Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: LAT. Product type: Radioimmunoassay, Cannabinoid(S). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: LAW. Product type: Theophylline Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: LAX. Product type: Lidocaine Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: LAY. Product type: Methotrexate Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: LAZ. Product type: N-Acetylprocainamide Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: LBA. Product type: Procainamide Control Materials. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3280. Implant flag: N. Life-sustain/support flag: N.

Official code: LBB. Product type: Dynamometer, Ac-Powered. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1240. Implant flag: N. Life-sustain/support flag: N.

Official code: LBC. Product type: Prosthesis, Finger, Constrained, Metal, Cemented. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3210. Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96 Implant flag: Y. Life-sustain/support flag: N.

Official code: LBE. Product type: Stroller, Adaptive. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: LBG. Product type: Device, Fluidized Therapy, Dry Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. Implant flag: N. Life-sustain/support flag: N.

Official code: LBH. Product type: Varnish, Cavity. Official classification: Class II. Official category: Dental. Regulation number: 872.3260. Implant flag: N. Life-sustain/support flag: N.

Official code: LBI. Product type: Unit, Neonatal Phototherapy. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5700. Implant flag: N. Life-sustain/support flag: N.

Official code: LBJ. Product type: Device, Vein Stabilization. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6980. Implant flag: N. Life-sustain/support flag: N.

Official code: LBK. Product type: Neurosurgical Ultrasonic Instruments. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LBL. Product type: Tube, Tympanostomy, Porous Polyethylene. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3880. Implant flag: Y. Life-sustain/support flag: N.

Official code: LBM. Product type: Porous Polyethylene Ossicular Replacement. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3450. Implant flag: Y. Life-sustain/support flag: N.

Official code: LBN. Product type: Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3495. Implant flag: Y. Life-sustain/support flag: N.

Official code: LBP. Product type: Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3450. Implant flag: Y. Life-sustain/support flag: N.

Official code: LBR. Product type: Ldl & Vldl Precipitation, Hdl. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: LBS. Product type: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: LBT. Product type: Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: LBW. Product type: Set, Dialysis, Single Needle (Co-Axial Flow). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: LBX. Product type: Pelvimeter, Internal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: LBZ. Product type: Enzyme Immunoassay, Quinidine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: LCA. Product type: Radioimmunoassay, Theophylline. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: LCC. Product type: Applicator, Ocular Pressure. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4610. Implant flag: N. Life-sustain/support flag: N.

Official code: LCD. Product type: Enzyme Immunoassay, Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: LCE. Product type: Radioimmunoassay, Netilmicin (I-125). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: LCG. Product type: Intestinal Splinting Tubes. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: LCH. Product type: Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: LCI. Product type: Automated Radioimmunoassay Systems, For Clinical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: LCJ. Product type: Tissue Expander And Accessories. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LCL. Product type: Radioimmunoassay, Phencyclidine. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LCM. Product type: Enzyme Immunoassay, Phencyclidine. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LCN. Product type: Scraper, Tongue. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. Implant flag: N. Life-sustain/support flag: N.

Official code: LCO. Product type: Platelet Factor 4 Radioimmunoassay. Official classification: Class II. Official category: Hematology. Regulation number: 864.7695. Implant flag: N. Life-sustain/support flag: N.

Official code: LCP. Product type: Assay, Glycosylated Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7470. Implant flag: N. Life-sustain/support flag: N.

Official code: LCQ. Product type: Fluorescent Immunoassay Gentamicin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: LCR. Product type: Fluorescent Immunoassay, Tobramycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: LCS. Product type: Radioimmunoassay, Digoxin (125-I). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: LCT. Product type: Radioimmunoassay, Digoxin (3-H). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: LCW. Product type: Radioimmunoassay, Digitoxin (125-I). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: LCX. Product type: Kit, Test, Pregnancy, Hcg, Over The Counter. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1155. Implant flag: N. Life-sustain/support flag: N.

Official code: LCY. Product type: U.V. Spectrometry, Theophylline. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: LCZ. Product type: U.V. Spectrometry, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: LDA. Product type: U.V. Spectrometry, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: LDB. Product type: U.V. Spectrometry, Carbamazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: LDC. Product type: U.V. Spectrometry, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: LDD. Product type: Dc-Defibrillator, Low-Energy, (Including Paddles). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5300. Implant flag: N. Life-sustain/support flag: Y.

Official code: LDE. Product type: Stethoscope, Manual. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.1875. Implant flag: N. Life-sustain/support flag: N.

Official code: LDF. Product type: Electrode, Pacemaker, Temporary. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3680. Implant flag: N. Life-sustain/support flag: Y.

Official code: LDG. Product type: Kit, Earmold, Impression. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: LDJ. Product type: Enzyme Immunoassay, Cannabinoids. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: LDK. Product type: Device, Sensing, Optical Contour. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LDM. Product type: Instrumentation, High Pressure Liquid Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: LDN. Product type: Enzymatic Radiochemical Assay, Amikacin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3035. Implant flag: N. Life-sustain/support flag: N.

Official code: LDO. Product type: Enzymatic Radiochemical Assay, Tobramycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: LDP. Product type: Colorimetry, Acetaminophen. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3030. Implant flag: N. Life-sustain/support flag: N.

Official code: LDR. Product type: Controller, Infusion, Intravascular, Electronic. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: LDS. Product type: Device, Pasteurization, Hot Water. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6991. Implant flag: N. Life-sustain/support flag: N.

Official code: LDW. Product type: Fixative, Acid Containing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: LDX. Product type: Fixative, Metallic Containing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: LDY. Product type: Fixative, Formalin-Containing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: LDZ. Product type: Fixative, Alcohol Containing. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: LEA. Product type: Preservative, Cytological. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: LEB. Product type: Mounting Media. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. Implant flag: N. Life-sustain/support flag: N.

Official code: LEC. Product type: Grinder, Tissue. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: LED. Product type: Stains, Chemical Solution. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: LEE. Product type: Stains, Dye Solution. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: LEF. Product type: Stains, Dye Powder. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: LEG. Product type: Enzyme Immunoassay, Valproic Acid. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: LEH. Product type: Radioimmunoassay, Vancomycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3950. Implant flag: N. Life-sustain/support flag: N.

Official code: LEI. Product type: Implant, Anti-Gastroesophageal Reflux. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LEJ. Product type: Booth, Sun Tan. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4635. Implant flag: N. Life-sustain/support flag: N.

Official code: LEK. Product type: Transilluminator (Diaphanoscope). Official classification: Class III. Official category: Radiology. Regulation number: 892.1990. Classified August 17, 1995: 60 fr 36639: Classification into Class III for the transilluminator (diaphanoscope or lightscanner) for breast evaluation requires manufacturers of transilluminators to submit safety and effectiveness tests for the device. Implant flag: N. Life-sustain/support flag: N.

Official code: LEL. Product type: Device, Sleep Assessment. Official classification: Class II. Official category: Neurology. Regulation number: 882.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: LEM. Product type: Human Lyophilized Dura Mater. Official classification: Class II. Official category: Neurology. Regulation number: 882.5975. Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d). Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271" the good tissue practice regulation http://www.Fda.Gov/cber/rules/gtp.Pdf became final effective may 25, 2005. It states that "on january 27, 2004, fda issued an interim final rule excepting human dura mater and human heart valve allografts from the definition of hct/p in § 1271.3(d) (69 fr 3823). Fda stated that, when the comprehensive framework is in place, fda intends that human dura mater and human heart valves will be subject to it, and that fda intends to revoke the interim rule at that time (69 fr 3823 and 3824). With the effective date of this final rule, fda is revoking the interim rule and revising the language in § 1271.3(d)." Implant flag: Y. Life-sustain/support flag: N.

Official code: LEQ. Product type: Detectors, Electrochemical, Liquid Chromatography. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2260. Implant flag: N. Life-sustain/support flag: N.

Official code: LER. Product type: Fluorescent Immunoassay, Theophylline. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: LES. Product type: Fluorescent Immunoassay, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: LET. Product type: Fluorescent Immunoassay, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: LEW. Product type: Thin Layer Chromatography, Theophylline. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: LEY. Product type: Set, Oral Administration. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: LEZ. Product type: Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact). Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LFA. Product type: Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient). Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LFB. Product type: Button, Nasal Septal. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LFC. Product type: Device, Caries Detection. Official classification: Class II. Official category: Dental. Regulation number: 872.1740. Implant flag: N. Life-sustain/support flag: N.

Official code: LFD. Product type: Saliva, Artificial. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LFE. Product type: Solution, Cold Sterilizing. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6885. Implant flag: N. Life-sustain/support flag: N.

Official code: LFF. Product type: Unit, Activation, Breath Control. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3920. Implant flag: N. Life-sustain/support flag: N.

Official code: LFG. Product type: Radioimmunoassay, Tricyclic Antidepressant Drugs. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3910. Intended to measure any of the tricyclic antidepressant drugs in serum or urine. Implant flag: N. Life-sustain/support flag: N.

Official code: LFH. Product type: U.V. Spectrometry, Tricyclic Antidepressant Drugs. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: LFI. Product type: High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: LFJ. Product type: Catheter, Subclavian. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: N.

Official code: LFK. Product type: Catheter, Femoral. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: Y.

Official code: LFL. Product type: Instrument, Ultrasonic Surgical. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LFM. Product type: Enzyme Immunoassay, Digitoxin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: LFN. Product type: Nephelometric Inhibition Immunoassay, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: LFO. Product type: Nephelometric Inhibition Immunoassay, Diphenylhydantoin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: LFP. Product type: Conductivity Rate, Urea Nitrogen. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1770. Implant flag: N. Life-sustain/support flag: N.

Official code: LFQ. Product type: Acid, Uric, Acid Reduction Of Ferric Ion. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. Implant flag: N. Life-sustain/support flag: N.

Official code: LFR. Product type: Glucose Dehydrogenase, Glucose. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: LFS. Product type: Radioreceptor Assay, Human Chorionic Gonadotropin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1155. Implant flag: N. Life-sustain/support flag: N.

Official code: LFT. Product type: Fluorescent Immunoassay, Primidone. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: LFW. Product type: Fluorescence Polarization Immunoassay, Tobramycin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: LFX. Product type: Enzyme Linked Immunoabsorbent Assay, Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: LFY. Product type: Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: LFZ. Product type: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: LGA. Product type: Device, Oxidase Test For Gonorrhea. Official classification: Class III. Official category: Microbiology. Regulation number: 866.2420. Implant flag: N. Life-sustain/support flag: N.

Official code: LGB. Product type: Gonococcal Antibody Tests. Official classification: Class III. Official category: Microbiology. Regulation number: 866.3290. Implant flag: N. Life-sustain/support flag: N.

Official code: LGC. Product type: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: LGD. Product type: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: LGE. Product type: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3530. Implant flag: Y. Life-sustain/support flag: N.

Official code: LGF. Product type: Component, Cast. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5940. Implant flag: N. Life-sustain/support flag: N.

Official code: LGG. Product type: Instrument, Cast Application/Removal, Manual. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: LGH. Product type: Instrument, Cast Removal, Ac-Powered. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.5960. Implant flag: N. Life-sustain/support flag: N.

Official code: LGI. Product type: Fluorescence Polarization Immunoassay, Carbamazepine. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: LGJ. Product type: Fluorescence Polarization Immunoassay, Amibacin. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3035. Implant flag: N. Life-sustain/support flag: N.

Official code: LGL. Product type: Assay, Bart'S, Hemoglobin. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Implant flag: N. Life-sustain/support flag: N.

Official code: LGM. Product type: Chamber, Patient Isolation. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5450. Implant flag: N. Life-sustain/support flag: N.

Official code: LGN. Product type: Chamber, Patient Transport Isolation. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5450. Implant flag: N. Life-sustain/support flag: N.

Official code: LGO. Product type: Test, Leukocyte Typing. Official classification: Class I. Official category: Hematology. Regulation number: 864.7675. Implant flag: N. Life-sustain/support flag: N.

Official code: LGP. Product type: Assay, Alpha-2-Antiplasmin. Official classification: Class II. Official category: Hematology. Regulation number: 864.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: LGQ. Product type: Fluorescence Polarization Immunoassay, Phenobarbital. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: LGR. Product type: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: LGS. Product type: Fluorescence Polarization Immunoassay, Theophylline. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3880. Implant flag: N. Life-sustain/support flag: N.

Official code: LGW. Product type: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LGX. Product type: Table, Examination, Medical, Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4960. Implant flag: N. Life-sustain/support flag: N.

Official code: LGY. Product type: Trypan Blue. Official classification: Class I. Official category: Hematology. Regulation number: 864.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: LGZ. Product type: Warmer, Thermal, Infusion Fluid. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: LHB. Product type: Timer, Apgar. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2930. Implant flag: N. Life-sustain/support flag: N.

Official code: LHC. Product type: Warmer, Irrigation Solution. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5950. Implant flag: N. Life-sustain/support flag: N.

Official code: LHD. Product type: Device, Fertility Diagnostic, Proceptive. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LHE. Product type: Controller, Closed-Loop Blood Glucose. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LHF. Product type: Warmer, Microwave, Infusion Fluid. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: LHG. Product type: Electrode, Spinal Epidural. Official classification: Class II. Official category: Neurology. Regulation number: 882.5880. Implant flag: Y. Life-sustain/support flag: N.

Official code: LHI. Product type: Set, I.V. Fluid Transfer. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: LHJ. Product type: Staphylococcus Aureus Protein A Insoluble. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: LHK. Product type: Antigen, Id, Candida Albicans. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: LHL. Product type: Reagents, Antibody, Legionella, Direct & Indirect Fluorescent. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: LHM. Product type: System, Thermographic, Liquid Crystal. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.2982. Implant flag: N. Life-sustain/support flag: N.

Official code: LHN. Product type: System, Radiation Therapy, Charged-Particle, Medical. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: LHO. Product type: Instrument, Quality-Assurance, Radiologic. Official classification: Class I. Official category: Radiology. Regulation number: 892.1940. Implant flag: N. Life-sustain/support flag: N.

Official code: LHP. Product type: System, Telethermographic (Sole Diagnostic Screen). Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2980. Implant flag: N. Life-sustain/support flag: N.

Official code: LHQ. Product type: System, Telethermographic (Adjunctive Use). Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.2980. Implant flag: N. Life-sustain/support flag: N.

Official code: LHR. Product type: System, Thermographic, Liquid Crystal (Sole Diagnostic Screen). Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.2982. Implant flag: N. Life-sustain/support flag: N.

Official code: LHT. Product type: Staphylococcus Aureus Somatic Antigens. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: LHW. Product type: Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3720. Implant flag: N. Life-sustain/support flag: N.

Official code: LHX. Product type: Trousers, Anti-Shock. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5800. Implant flag: N. Life-sustain/support flag: N.

Official code: LHY. Product type: Electrode, Stabilized Epidural Spinal. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LHZ. Product type: Viscometer, Mucus, Cervical. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1040. Implant flag: N. Life-sustain/support flag: N.

Official code: LIA. Product type: Antigens, All Groups, Shigella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: LIB. Product type: Device, General Purpose, Microbiology, Diagnostic. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LIC. Product type: Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3390. Implant flag: N. Life-sustain/support flag: N.

Official code: LIE. Product type: Reagent/Device, Inoculum Calibration. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: LIF. Product type: Dialyzer Reprocessing System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: LIG. Product type: Radioassay, Intrinsic Factor Blocking Antibody. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1810. Implant flag: N. Life-sustain/support flag: N.

Official code: LIH. Product type: Interferential Current Therapy. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: LII. Product type: Monitor, Intracranial Pressure, Implanted. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LIJ. Product type: Peroxidase Anti-Peroxidase Immunohistochemical Stain. Official classification: Class I. Official category: Pathology. Regulation number: 864.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: LIL. Product type: Monitor, Penile Tumescence. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LIM. Product type: Test, Screening, For D Positive Fetal Rbc'S. Official classification: Class II. Official category: Hematology. Regulation number: 864.7455. Implant flag: N. Life-sustain/support flag: N.

Official code: LIN. Product type: Antisera, Conjugated Fluorescent, Cytomegalovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: LIO. Product type: Device, Specimen Collection. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: LIP. Product type: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: LIQ. Product type: Enzyme Linked Immunoabsorbent Assay, Rotavirus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3405. Implant flag: N. Life-sustain/support flag: N.

Official code: LIR. Product type: Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3390. Implant flag: N. Life-sustain/support flag: N.

Official code: LIT. Product type: Catheter, Angioplasty, Peripheral, Transluminal. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: LIW. Product type: Fibrillator, Ac. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LIX. Product type: Aid, Cardiopulmonary Resuscitation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5210. CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software Implant flag: N. Life-sustain/support flag: N.

Official code: LIZ. Product type: Assay, T Lymphocyte Surface Marker. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: LJB. Product type: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. The qualitative detection of measles specific IgG antibodies in serum or plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: LJC. Product type: Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group). Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: LJD. Product type: Assay, B Lymphocyte Marker. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: LJE. Product type: Catheter, Nephrostomy. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LJF. Product type: Device, Antimicrobial Drug Removal. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2560. Implant flag: N. Life-sustain/support flag: N.

Official code: LJG. Product type: Quality Control Slides. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LJH. Product type: System, Irrigation, Urological. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: LJK. Product type: Antisera, If, Toxoplasma Gondii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: LJL. Product type: Detectors And Removers, Lice, (Including Combs). Official classification: Class I. Official category: General Hospital. Regulation number: 880.5960. Implant flag: N. Life-sustain/support flag: N.

Official code: LJM. Product type: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LJN. Product type: Antibody Igm, If, Epstein-Barr Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: LJO. Product type: Antigen, Iha, Cytomegalovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: LJP. Product type: Antiserum, Fluorescent, Chlamydia Trachomatis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: LJS. Product type: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5970. Implant flag: Y. Life-sustain/support flag: N.

Official code: LJT. Product type: Port & Catheter, Implanted, Subcutaneous, Intravascular. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5965. Implant flag: Y. Life-sustain/support flag: N.

Official code: LJW. Product type: Tracheotome. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: LJX. Product type: Test, Urine Leukocyte. Official classification: Class I. Official category: Hematology. Regulation number: 864.7675. Implant flag: N. Life-sustain/support flag: N.

Official code: LJY. Product type: Enzyme Linked Immunoabsorbent Assay, Mumps Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3380. Implant flag: N. Life-sustain/support flag: N.

Official code: LJZ. Product type: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3375. Implant flag: N. Life-sustain/support flag: N.

Official code: LKA. Product type: Culture Media, Antimicrobial Susceptibility Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: LKB. Product type: Pad, Alcohol, Device Disinfectant. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LKC. Product type: Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: LKD. Product type: Monitor, Carbon-Dioxide, Cutaneous. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2480. Implant flag: N. Life-sustain/support flag: N.

Official code: LKF. Product type: Cannula, Manipulator/Injector, Uterine. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: LKG. Product type: Port & Catheter, Implanted, Subcutaneous, Intraventricular. Official classification: Class II. Official category: Neurology. Regulation number: 882.5550. Implant flag: Y. Life-sustain/support flag: N.

Official code: LKH. Product type: Antisera, Immunoperoxidase, Chlamydia Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: LKI. Product type: Antisera, Fluorescent, Chlamydia Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: LKJ. Product type: Antinuclear Antibody, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LKK. Product type: Pump, Infusion, Implanted, Programmable. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LKL. Product type: Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5420. Implant flag: N. Life-sustain/support flag: N.

Official code: LKM. Product type: Counter, Urine Particle. Official classification: Class II. Official category: Hematology. Regulation number: 864.5200. Implant flag: N. Life-sustain/support flag: N.

Official code: LKN. Product type: Separator, Automated, Blood Cell And Plasma, Therapeutic. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LKO. Product type: Anti-Rnp Antibody, Antigen And Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LKP. Product type: Anti-Sm Antibody, Antigen And Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LKQ. Product type: Antibody Igm,If, Cytomegalovirus Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: LKS. Product type: Device, Parasite Concentration. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2900. Implant flag: N. Life-sustain/support flag: N.

Official code: LKT. Product type: Respiratory Syncytial Virus, Antigen, Antibody, Ifa. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3480. Implant flag: N. Life-sustain/support flag: N.

Official code: LKV. Product type: Enzyme Immunoassay, Fetal Fibronectin. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LKW. Product type: Laser, Neurosurgical. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LKX. Product type: Device, Thermal, Hemorrhoids. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LKY. Product type: Device, External Penile Rigidity. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5020. Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices. Implant flag: N. Life-sustain/support flag: N.

Official code: LKZ. Product type: Red-Cell Count By Photometry. Official classification: Class II. Official category: Hematology. Regulation number: 864.7100. Implant flag: N. Life-sustain/support flag: N.

Official code: LLA. Product type: Direct Agglutination Test, Toxoplasma Gondii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: LLB. Product type: System, Blood, Extracorporeal And Accessories. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: LLD. Product type: Port & Catheter, Implanted, Subcutaneous, Intraperitoneal. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5965. Implant flag: Y. Life-sustain/support flag: N.

Official code: LLE. Product type: Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LLF. Product type: Laser, Neurosurgical, Argon. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LLG. Product type: Kit, Igg, Platelet Associated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5425. Implant flag: N. Life-sustain/support flag: N.

Official code: LLH. Product type: Reagents, Clostridium Difficile Toxin. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LLI. Product type: Bed, Therapeutic, Ac-Powered, Adjustable Home-Use. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LLK. Product type: Legging, Compression, Non-Inflatable. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5780. Implant flag: N. Life-sustain/support flag: N.

Official code: LLL. Product type: Extractable Antinuclear Antibody, Antigen And Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LLM. Product type: Test, Antigen, Nuclear, Epstein-Barr Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: LLN. Product type: Device, Vibration Threshold Measurement. Official classification: Class I. Official category: Neurology. Regulation number: 882.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: LLO. Product type: Laser, Neodymium:Yag, Pulmonary Surgery. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: LLP. Product type: Laser For Pain Therapy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LLQ. Product type: Cap, Cervical, Contraceptive. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LLW. Product type: Laser, Neodymium:Yag For Gynecologic Use. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4550. Implant flag: N. Life-sustain/support flag: N.

Official code: LLX. Product type: Catheter, Sampling, Chorionic Villus. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LLZ. Product type: System, Image Processing, Radiological. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: LMA. Product type: Digitizer, Image, Radiological. Official classification: Class II. Official category: Radiology. Regulation number: 892.2030. Implant flag: N. Life-sustain/support flag: N.

Official code: LMB. Product type: Device, Digital Image Storage, Radiological. Official classification: Class I. Official category: Radiology. Regulation number: 892.2010. Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images. Implant flag: N. Life-sustain/support flag: N.

Official code: LMC. Product type: Camera, Multi Format, Radiological. Official classification: Class II. Official category: Radiology. Regulation number: 892.2040. Implant flag: N. Life-sustain/support flag: N.

Official code: LMD. Product type: System, Digital Image Communications, Radiological. Official classification: Class I. Official category: Radiology. Regulation number: 892.2020. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. Implant flag: N. Life-sustain/support flag: N.

Official code: LME. Product type: Monitor, Blood-Flow, Cerebral, Thermal Diffusion. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LMF. Product type: Agent, Absorbable Hemostatic, Collagen Based. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4490. Implant flag: Y. Life-sustain/support flag: N.

Official code: LMG. Product type: Agent, Absorbable Hemostatic, Non-Collagen Based. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4490. Implant flag: Y. Life-sustain/support flag: N.

Official code: LMH. Product type: Implant, Dermal, For Aesthetic Use. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LMI. Product type: Implant, Collagen For Non-Aesthetic Use. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LML. Product type: Ligaments And Tendons, Synthetic. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LMN. Product type: Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LMQ. Product type: Device, Peritoneal Access, Subcutaneous, Implanted. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LMS. Product type: Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4490. Implant flag: N. Life-sustain/support flag: N.

Official code: LMW. Product type: Solution, Removal, Carries. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LMY. Product type: Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LMZ. Product type: Applicator, Hyperthermia, Interstitial. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNB. Product type: Applicator, Hyperthermia, Deep Heating, Ultrasound. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNC. Product type: Applicator, Hyperthermia, Superficial, Rf/Microwave. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNH. Product type: System, Nuclear Magnetic Resonance Imaging. Official classification: Class II. Official category: Radiology. Regulation number: 892.1000. Implant flag: N. Life-sustain/support flag: N.

Official code: LNI. Product type: System, Nuclear Magnetic Resonance Spectroscopic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1000. Implant flag: N. Life-sustain/support flag: N.

Official code: LNJ. Product type: Analyzer, Chromosome, Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.5260. Implant flag: N. Life-sustain/support flag: N.

Official code: LNK. Product type: Laser For Gastro-Urology Use. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Implant flag: N. Life-sustain/support flag: N.

Official code: LNL. Product type: Stimulator, Electrical For Sperm Collection. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNM. Product type: Agent, Bulking, Injectable For Gastro-Urology Use. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNQ. Product type: Intestinal Stimulator. Official classification: HDE. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNR. Product type: System, Photopheresis, Extracorporeal. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNS. Product type: Lithotriptor, Extracorporeal Shock-Wave, Urological. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5990. Implant flag: N. Life-sustain/support flag: N.

Official code: LNW. Product type: Paper, Obstetric Ph. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1550. Implant flag: N. Life-sustain/support flag: N.

Official code: LNY. Product type: Catheter, Percutaneous, Long Term, Intraspinal. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LNZ. Product type: Changer, Tube, Endotracheal. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5730. Implant flag: N. Life-sustain/support flag: N.

Official code: LOA. Product type: Device, Testicular Hypothermia. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOB. Product type: Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOC. Product type: System, Rf/Microwave Hyperthermia, Cancer Treatment. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOD. Product type: Bone Cement. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. Implant flag: Y. Life-sustain/support flag: N.

Official code: LOE. Product type: Stimulator, Invasive Bone Growth. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOF. Product type: Stimulator, Bone Growth, Non-Invasive. Official classification: Class II. Official category: Orthopedic. Regulation number: 890.5870. A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators. Implant flag: N. Life-sustain/support flag: N.

Official code: LOG. Product type: Catheter, Balloon For Retinal Reattachment. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOH. Product type: System, Identification, Contact Lens. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOI. Product type: Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOJ. Product type: Kit, Test,Alpha-Fetoprotein For Testicular Cancer. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: LOK. Product type: Kit, Test, Alpha-Fetoprotein For Neural Tube Defects. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOL. Product type: Hepatitis A Test (Antibody And Igm Antibody). Official classification: Class II. Official category: Microbiology. Regulation number: 866.3310. Implant flag: N. Life-sustain/support flag: N.

Official code: LOM. Product type: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen). Official classification: Class II. Official category: Microbiology. Regulation number: 866.3172. In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period. Implant flag: N. Life-sustain/support flag: N.

Official code: LON. Product type: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1645. Implant flag: N. Life-sustain/support flag: N.

Official code: LOO. Product type: Reagent, Leishmanii Serological. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: LOP. Product type: Solution, Antimicrobial. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: LOQ. Product type: Device, General Purpose, Hematology. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: LOT. Product type: Pulse-Generator, Program Module. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LOX. Product type: Catheters, Transluminal Coronary Angioplasty, Percutaneous. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5100. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. Implant flag: N. Life-sustain/support flag: N.

Official code: LOZ. Product type: Artificial Heart. Official classification: Class III. Official category: Unknown. P030011 Implant flag: Y. Life-sustain/support flag: N.

Official code: LPA. Product type: System, Esophageal Pacing. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LPB. Product type: Cardiac Ablation Percutaneous Catheter. Official classification: Class III. Official category: Unknown. This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae]. Implant flag: N. Life-sustain/support flag: N.

Official code: LPC. Product type: Device, Angioplasty, Laser, Coronary. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LPF. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LPG. Product type: Material, Dressing, Surgical, Polylactic Acid. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LPH. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3358. Implant flag: Y. Life-sustain/support flag: N.

Official code: LPI. Product type: Kit, Assay, Progesterone Receptor. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: LPJ. Product type: Kit, Assay, Estrogen Receptor. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: LPL. Product type: Lenses, Soft Contact, Daily Wear. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: LPM. Product type: Lenses, Soft Contact, Extended Wear. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: LPN. Product type: Accessories, Soft Lens Products. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5928. Implant flag: N. Life-sustain/support flag: N.

Official code: LPO. Product type: Gases Used Within Eye To Place Pressure On Detached Retina. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.4270. Implant flag: N. Life-sustain/support flag: N.

Official code: LPP. Product type: Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2500. Implant flag: N. Life-sustain/support flag: N.

Official code: LPQ. Product type: Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep. Official classification: Class II. Official category: Orthopedic. Regulation number: 890.5870. A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators. Implant flag: N. Life-sustain/support flag: N.

Official code: LPS. Product type: Urinary Homocystine (Nonquantitative) Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1377. Implant flag: N. Life-sustain/support flag: N.

Official code: LPT. Product type: System, Test, Urinary Methylmalonic Acid. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1509. Implant flag: N. Life-sustain/support flag: N.

Official code: LPW. Product type: System, Test, Oxalate. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1542. Implant flag: N. Life-sustain/support flag: N.

Official code: LPX. Product type: Radioceptor Assay, Neuroleptic Drugs. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. Implant flag: N. Life-sustain/support flag: N.

Official code: LPZ. Product type: Container, Frozen Donor Tissue Storage. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LQA. Product type: Media, Reusable Image. Official classification: Class I. Official category: Radiology. Regulation number: 892.1840. Implant flag: N. Life-sustain/support flag: N.

Official code: LQB. Product type: Medical Computers And Software For Ophthalmic Use. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LQC. Product type: Lithotriptor, Biliary Mechanical. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: LQD. Product type: Recorder, Attention Task Performance. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LQE. Product type: Implant, Corneal, Refractive. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LQF. Product type: Dna-Reagents, Mycobacterium Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3370. Implant flag: N. Life-sustain/support flag: N.

Official code: LQG. Product type: Dna-Reagents, Mycoplasma Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3375. Implant flag: N. Life-sustain/support flag: N.

Official code: LQH. Product type: Dna-Reagents, Legionella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: LQI. Product type: Hepatitis Delta Serological Reagents. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LQJ. Product type: Lens, Surgical, Laser, Accesssory, Ophthalmic Laser. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4390. Implant flag: N. Life-sustain/support flag: N.

Official code: LQK. Product type: Home Uterine Activity Monitor. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2730. Implant flag: N. Life-sustain/support flag: N.

Official code: LQL. Product type: Gram Positive Identification Panel. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LQM. Product type: Gram Negative Identification Panel. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LQN. Product type: Latex Agglutination Assay, Rubella. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: LQO. Product type: Dna-Reagents, Campylobacter Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: LQP. Product type: Campylobacter Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: LQQ. Product type: Columns, Immunoadsorption In Extracorporeal Systems. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LQR. Product type: Dislodger, Stone, Biliary. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5010. Implant flag: N. Life-sustain/support flag: N.

Official code: LQS. Product type: Spermatocele, Alloplastic. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LQW. Product type: Test, Temperature Discrimination. Official classification: Class I. Official category: Neurology. Regulation number: 882.1200. Implant flag: N. Life-sustain/support flag: N.

Official code: LQX. Product type: Device, Finger-Sucking. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: LQY. Product type: Locator, Root Apex. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LQZ. Product type: Device, Jaw Repositioning. Official classification: Class II. Official category: Dental. Regulation number: 872.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: LRA. Product type: Hearing Aid, Tactile. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LRB. Product type: Face Plate Hearing Aid. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: LRC. Product type: Instrument, Ent Manual Surgical. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: LRD. Product type: Applicator, Ent Drug. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: LRE. Product type: Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Implant flag: N. Life-sustain/support flag: N.

Official code: LRF. Product type: Candida Spp., Direct Antigen, Id. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: LRG. Product type: Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: LRH. Product type: Instrument For Auto Reader Of Overnight Microorganism Identification System. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LRI. Product type: Ph Meter For Dialysis Hydrogen Ion Concentration. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: LRJ. Product type: Disinfectant, Medical Devices. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6890. Implant flag: N. Life-sustain/support flag: N.

Official code: LRK. Product type: Device, Anti-Snoring. Official classification: Class II. Official category: Dental. Regulation number: 872.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: LRL. Product type: Cushion, Hemorrhoid. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LRM. Product type: Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LRN. Product type: Wire, Surgical. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: LRO. Product type: General Surgery Tray. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: LRP. Product type: Tray, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LRQ. Product type: Tracheostomy And Nasal Suctioning Kit. Official classification: Class I. Official category: Unknown. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: LRR. Product type: First Aid Kit With Drug. Official classification: Not classified. Official category: Unknown. Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: LRS. Product type: I.V. Start Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: LRT. Product type: Indicator, Sterilization. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: LRW. Product type: Scissors, General, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LRX. Product type: Case, Contact Lens. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5928. Implant flag: N. Life-sustain/support flag: N.

Official code: LRY. Product type: Punch, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LRZ. Product type: Screwdriver, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LSA. Product type: Vise, Bench, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LSB. Product type: Unit, Fluidotherapy. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LSC. Product type: Neisseria Controls. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LSD. Product type: Rubella, Other Assays. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: LSE. Product type: Epstein-Barr Virus, Other. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: LSF. Product type: Dna-Reagents, Epstein-Barr Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: LSG. Product type: Candida Species, Antibody Detection. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: LSH. Product type: Antigen, Blastomyces Dermatitidis, Other. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: LSI. Product type: Antiserum, Blastomyces Dermatitidis, Other. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: LSJ. Product type: Antigen, Rubella, Other. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. Implant flag: N. Life-sustain/support flag: N.

Official code: LSK. Product type: Dna-Reagents, Chlamydia. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: LSL. Product type: Dna-Reagents, Neisseria. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3390. Implant flag: N. Life-sustain/support flag: N.

Official code: LSM. Product type: Dna-Reagents, Salmonella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3550. Implant flag: N. Life-sustain/support flag: N.

Official code: LSN. Product type: Dna-Reagents, Shigella Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3660. Implant flag: N. Life-sustain/support flag: N.

Official code: LSO. Product type: Dna-Reagents, Cytomegalovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3175. Implant flag: N. Life-sustain/support flag: N.

Official code: LSQ. Product type: Reagent, Rickettsia Serological. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. Implant flag: N. Life-sustain/support flag: N.

Official code: LSR. Product type: Reagent, Borrelia Serological Reagent. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: LSW. Product type: Anti-Dna Antibody, Antigen And Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: LSX. Product type: Controller, Closed-Loop, Blood-Pressure. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LSY. Product type: Ultrasound, Hyperthermia, Cancer Treatment. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LSZ. Product type: Ventilator, High Frequency. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTA. Product type: Fluid, Hysteroscopy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTB. Product type: Cyclosporine Radioimmunoassay. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1235. Implant flag: N. Life-sustain/support flag: N.

Official code: LTC. Product type: Hyaline Membrane Disease Assay. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTD. Product type: Paraquat Assay. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTF. Product type: Stimulator, Salivary System. Official classification: Class II. Official category: Dental. Regulation number: 872.5560. Implant flag: N. Life-sustain/support flag: N.

Official code: LTG. Product type: Paste, Injectable For Vocal Cord Augmentation. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTI. Product type: Implant, Intragastric For Morbid Obesity. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LTJ. Product type: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: LTK. Product type: Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125). Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: LTO. Product type: Spacer, Cement. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3320. Implant flag: Y. Life-sustain/support flag: N.

Official code: LTQ. Product type: Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTS. Product type: Test Reagents, Neisseria Gonorrhoeae Biochemical. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LTT. Product type: Panels, Test, Susceptibility, Antimicrobial. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: LTW. Product type: Susceptibility Test Cards, Antimicrobial. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: LTX. Product type: Discs, Elution. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1620. Implant flag: N. Life-sustain/support flag: N.

Official code: LTY. Product type: Fluid, Cytological Collection. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LTZ. Product type: Condom With Nonoxynol-9. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5310. Implant flag: N. Life-sustain/support flag: N.

Official code: LWA. Product type: Prosthesis, Ligament, Ptfe. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LWB. Product type: Stimulator, Functional Neuromuscular, Scoliosis. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LWE. Product type: Bone Marrow Collection/Transfusion Kit. Official classification: Class II. Official category: Unknown. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: LWF. Product type: Dilator, Nasal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3900. Implant flag: N. Life-sustain/support flag: N.

Official code: LWG. Product type: Surgical Table Cushion. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4950. Implant flag: N. Life-sustain/support flag: N.

Official code: LWH. Product type: Counter, Sponge, Surgical. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2740. Implant flag: N. Life-sustain/support flag: N.

Official code: LWI. Product type: Ultrasound, Sinus. Official classification: Class II. Official category: Radiology. Regulation number: 892.1560. Implant flag: N. Life-sustain/support flag: N.

Official code: LWJ. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3360. Implant flag: Y. Life-sustain/support flag: N.

Official code: LWK. Product type: Razor, Surgical. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LWL. Product type: Fluid, Intraocular. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.4275. Implant flag: N. Life-sustain/support flag: N.

Official code: LWM. Product type: Device, Electrical Dental Anesthesia. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LWO. Product type: Pulse-Generator, Single Chamber, Sensor Driven, Implantable. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LWP. Product type: Implantable Pulse Generator, Pacemaker (Non-Crt). Official classification: Class III. Official category: Unknown. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary. Implant flag: Y. Life-sustain/support flag: Y.

Official code: LWQ. Product type: Heart-Valve, Mechanical. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: Y.

Official code: LWR. Product type: Heart-Valve, Non-Allograft Tissue. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LWS. Product type: Implantable Cardioverter Defibrillator (Non-Crt). Official classification: Class III. Official category: Unknown. These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary. Implant flag: Y. Life-sustain/support flag: Y.

Official code: LWT. Product type: Occluder, Balloon, Vena-Cava. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LWW. Product type: Pulse-Generator, Single Chamber, Single. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LWX. Product type: Device. Laser Peripheral Angioplasty. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LWZ. Product type: Tissue Graft Of Less Than 6mm. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXA. Product type: Tissue Graft Of 6mm And Greater. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LXB. Product type: Hearing Aid, Bone Conduction. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3302. Implant flag: N. Life-sustain/support flag: N.

Official code: LXC. Product type: Monitor, Pressure, Intracompartmental. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXE. Product type: Doppler, Fetal, Ultrasound. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: LXF. Product type: Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat. Official classification: Class III. Official category: Physical Medicine. Regulation number: 890.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: LXG. Product type: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: LXH. Product type: Orthopedic Manual Surgical Instrument. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: LXI. Product type: Guide, Drill, Ligament. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: LXJ. Product type: Interactive Rehabilitation Exercise Devices. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5360. Implant flag: N. Life-sustain/support flag: N.

Official code: LXK. Product type: Scrapper, Skin Specimen. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LXM. Product type: Manipulator, Plunger-Like Joint. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXN. Product type: Probe, Test, Heart-Valve. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: LXP. Product type: Plug, Scleral. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4155. Intended to provide temporary closure of a scleral incision during an ophthalmic procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: LXQ. Product type: Cup, Eye. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXR. Product type: Laser, Microsurgical Argon, For Use In Otology. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4490. Implant flag: N. Life-sustain/support flag: N.

Official code: LXS. Product type: Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4392. Implant flag: N. Life-sustain/support flag: N.

Official code: LXT. Product type: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: LXU. Product type: Laser For Wound Healing. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXV. Product type: Apparatus, Vestibular Analysis. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXW. Product type: Column, Adsorption, Low Density, Lipoprotein. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LXY. Product type: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LXZ. Product type: Guard, Instrument. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LYA. Product type: Splint, Intranasal Septal. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4780. Implant flag: N. Life-sustain/support flag: N.

Official code: LYC. Product type: Bone Grafting Material, Synthetic. Official classification: Class II. Official category: Dental. Regulation number: 872.3930. A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. Implant flag: Y. Life-sustain/support flag: N.

Official code: LYE. Product type: Cytokeratins. Official classification: Class II. Official category: Immunology. Regulation number: 866.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: LYF. Product type: Pneumocystis Carinii. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3780. Implant flag: N. Life-sustain/support flag: N.

Official code: LYG. Product type: Massager, Therapeutic, Manual. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: LYH. Product type: Arthrometer. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.1615. Implant flag: N. Life-sustain/support flag: N.

Official code: LYI. Product type: Stimulator, Subcortical, Implanted For Epilepsy. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LYJ. Product type: Stimulator, Autonomic Nerve, Implanted For Epilepsy. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LYK. Product type: Angioscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: LYL. Product type: Accessories, Solution, Ultrasonic Cleaners For Lenses. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5928. Implant flag: N. Life-sustain/support flag: N.

Official code: LYN. Product type: Apparatus, Visual Reinforcement Audiometric. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: LYP. Product type: Accessories, Fixation, Spinal Interlaminal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3050. Implant flag: Y. Life-sustain/support flag: N.

Official code: LYQ. Product type: Accessories, Fixation, Spinal Intervertebral Body. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: LYR. Product type: Helicobacter Pylori. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: LYS. Product type: Bone Mill. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Implant flag: N. Life-sustain/support flag: N.

Official code: LYT. Product type: Fixation Accessory. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: LYU. Product type: Accessory, Surgical Apparel. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. Implant flag: N. Life-sustain/support flag: N.

Official code: LYV. Product type: Label Or Tag, Sterile. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: LYX. Product type: Media, Corneal Storage. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LYY. Product type: Latex Patient Examination Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. Implant flag: N. Life-sustain/support flag: N.

Official code: LYZ. Product type: Vinyl Patient Examination Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. Implant flag: N. Life-sustain/support flag: N.

Official code: LZA. Product type: Polymer Patient Examination Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. Implant flag: N. Life-sustain/support flag: N.

Official code: LZB. Product type: Finger Cot. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. Implant flag: N. Life-sustain/support flag: N.

Official code: LZC. Product type: Medical Glove, Specialty. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc. Implant flag: N. Life-sustain/support flag: N.

Official code: LZD. Product type: Joint, Temporomandibular, Implant. Official classification: Class III. Official category: Dental. Regulation number: 872.3940. Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint. Implant flag: Y. Life-sustain/support flag: N.

Official code: LZE. Product type: Isometer. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.1520. Implant flag: N. Life-sustain/support flag: N.

Official code: LZF. Product type: Pump, Infusion, Analytical Sampling. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: LZG. Product type: Pump, Infusion, Insulin. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: LZH. Product type: Pump, Infusion, Enteral. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: LZI. Product type: Device, Assistive Listening. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: LZJ. Product type: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: LZK. Product type: Implant, Malar. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3550. Implant flag: Y. Life-sustain/support flag: N.

Official code: LZL. Product type: Micro-Condom. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5320. Call for PMAs to be filed by 9/12/02 per 67 FR 40849 on 6/14/02 Implant flag: N. Life-sustain/support flag: N.

Official code: LZM. Product type: Guard, Skin Graft. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. Implant flag: N. Life-sustain/support flag: N.

Official code: LZN. Product type: Cement Obturator. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: LZO. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3353. Implant flag: Y. Life-sustain/support flag: N.

Official code: LZP. Product type: Aid, Surgical, Viscoelastic. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.4275. Implant flag: N. Life-sustain/support flag: N.

Official code: LZQ. Product type: Tissue Adhesive For Ophthalmic Use. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LZR. Product type: Ultrasound, Cyclodestructive. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5350. An ultrasound cyclodestructive device uses high intensity focused ultrasound (HIFU) energy to create lesions in the ciliary body and/or trabecular meshwork to reduce intraocular pressure in glaucoma patients. Implant flag: N. Life-sustain/support flag: N.

Official code: LZS. Product type: Excimer Laser System. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LZU. Product type: Plug, Punctum. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LZV. Product type: System, Cement Removal Extraction. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4580. Implant flag: N. Life-sustain/support flag: N.

Official code: LZW. Product type: Monitor, Spine Curvature. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: LZY. Product type: Prosthesis, Hip, Hemi-, Femoral, Metal Ball. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3360. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAA. Product type: Monitor, Fetal Doppler Ultrasound. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: MAB. Product type: Marker, Cardiopulmonary Bypass (Vein Marker). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: MAC. Product type: Decontamination Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: MAD. Product type: Catheter, Percutaneous (Valvuloplasty). Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MAE. Product type: Occluder, Patent Ductus, Arteriosus. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAF. Product type: Stent, Coronary. Official classification: Class III. Official category: Unknown. The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAH. Product type: Hearing Aid, Bone Conduction, Implanted. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3302. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAI. Product type: Fastener, Fixation, Biodegradable, Soft Tissue. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAJ. Product type: Catheter, Percutaneous, Intraspinal, Short Term. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. Implant flag: N. Life-sustain/support flag: N.

Official code: MAL. Product type: Graft, Vascular, Synthetic/Biologic Composite. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3450. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAM. Product type: Dna-Probe, B And T Lymphocyte. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. Implant flag: N. Life-sustain/support flag: N.

Official code: MAN. Product type: Assay, Interleukin. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MAO. Product type: Dna-Probe, Human Chromosome. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MAQ. Product type: Kit, Dna Detection, Human Papillomavirus. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MAR. Product type: Cyclosporine And Metabolites Serum Assay. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1235. Implant flag: N. Life-sustain/support flag: N.

Official code: MAU. Product type: Eraser, Dental Stain. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. Implant flag: N. Life-sustain/support flag: N.

Official code: MAV. Product type: Syringe, Balloon Inflation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: MAW. Product type: Marker, Suture Identification. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: MAX. Product type: Intervertebral Fusion Device With Bone Graft, Lumbar. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3080. Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. Implant flag: Y. Life-sustain/support flag: N.

Official code: MAY. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3353. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBB. Product type: Bone Cement, Antibiotic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBD. Product type: Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBF. Product type: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3670. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBH. Product type: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3565. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBI. Product type: Fastener, Fixation, Nondegradable, Soft Tissue. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBJ. Product type: Fastener, Fixation, Biodegradable, Hard Tissue. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBL. Product type: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3358. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBP. Product type: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor). Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3045. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBQ. Product type: Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MBS. Product type: Filler, Bone Void, Non-Osteoinduction. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBT. Product type: Dna-Probe, Reagent, Histoplasma Capsulatum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: MBU. Product type: Single-Use Internal Condom. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5340. For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded. Implant flag: N. Life-sustain/support flag: N.

Official code: MBV. Product type: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3560. Implant flag: Y. Life-sustain/support flag: N.

Official code: MBX. Product type: Stimulator, Thalamic, Epilepsy, Implanted. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MCA. Product type: Tape, Surgical, Internal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: MCB. Product type: Antigen, C. Difficile. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: MCC. Product type: Dna-Probe, Haemophilus Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: MCD. Product type: Antigen, Ebv, Capsid. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3235. Implant flag: N. Life-sustain/support flag: N.

Official code: MCE. Product type: Respiratory Syncytial Virus - Elisa. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3480. Implant flag: N. Life-sustain/support flag: N.

Official code: MCF. Product type: Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. Implant flag: N. Life-sustain/support flag: N.

Official code: MCG. Product type: Dna-Probe, Agent, Listeria. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3355. Implant flag: N. Life-sustain/support flag: N.

Official code: MCH. Product type: Clip, Hemostatic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Implant flag: Y. Life-sustain/support flag: N.

Official code: MCI. Product type: Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MCK. Product type: Device, Voice Amplification. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3730. Implant flag: N. Life-sustain/support flag: N.

Official code: MCL. Product type: Kit, Test, In Vitro Periodontal. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MCM. Product type: Implant, Cochlear. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MCN. Product type: Barrier, Absorbable, Adhesion. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MCP. Product type: Stimulator, Fetal, Acoustic. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MCS. Product type: Dna-Probe, Staphylococcus Aureus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3700. Implant flag: N. Life-sustain/support flag: N.

Official code: MCT. Product type: Dna-Probe, Strep Pneumoniae. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: MCV. Product type: Spinal Pedicle Screw, Fixation, Appliance System. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MCW. Product type: Catheter, Peripheral, Atherectomy. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4875. Implant flag: N. Life-sustain/support flag: N.

Official code: MCX. Product type: Catheter, Coronary, Atherectomy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MCY. Product type: Wound Dressing Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5075. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: MCZ. Product type: Suture Removal Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: MDA. Product type: Elastomer, Silicone, For Scar Management. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4025. Implant flag: N. Life-sustain/support flag: N.

Official code: MDB. Product type: System, Blood Culturing. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2560. Implant flag: N. Life-sustain/support flag: N.

Official code: MDC. Product type: Dna-Probe - Blastomyces Dermatitidis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: MDD. Product type: Device, Dermal Replacement. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MDE. Product type: Dna-Probe, Reagents, Cryptococcal. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: MDF. Product type: Dna-Probe, Reagents, Coccidioides Immitis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3135. Implant flag: N. Life-sustain/support flag: N.

Official code: MDG. Product type: System, Intrafallopian Cannula. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: MDI. Product type: Prosthesis, Rib Replacement. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. In children with or at risk of developing Thoracic Insufficiency Syndrome, the expandable rib prosthesis devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. The devices allow assembly in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome. Implant flag: Y. Life-sustain/support flag: N.

Official code: MDJ. Product type: Reagents, Cysticercosis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: MDK. Product type: Dna-Probe, Reagents, Streptococcal. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. Implant flag: N. Life-sustain/support flag: N.

Official code: MDL. Product type: Implant, Transmandibular. Official classification: Class II. Official category: Dental. Regulation number: 872.4760. Implant flag: Y. Life-sustain/support flag: N.

Official code: MDM. Product type: Instrument, Manual, Surgical, General Use. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: MDP. Product type: Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MDR. Product type: Binder, Medical, Therapeutic. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5160. Implant flag: N. Life-sustain/support flag: N.

Official code: MDS. Product type: Sensor, Glucose, Invasive. Official classification: Class III. Official category: Unknown. The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Implant flag: N. Life-sustain/support flag: N.

Official code: MDT. Product type: Elisa, Trichinella Spiralis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3850. Implant flag: N. Life-sustain/support flag: N.

Official code: MDU. Product type: Antigen, Elisa, Cryptococcus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3165. Implant flag: N. Life-sustain/support flag: N.

Official code: MDZ. Product type: Cleaners, Medical Devices. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6992. Implant flag: N. Life-sustain/support flag: N.

Official code: MEA. Product type: Pump, Infusion, Pca. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: MEB. Product type: Pump, Infusion, Elastomeric. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: MEC. Product type: Disinfector, Medical Devices. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6992. Implant flag: N. Life-sustain/support flag: N.

Official code: MED. Product type: Sterilant, Medical Devices. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6885. Implant flag: N. Life-sustain/support flag: N.

Official code: MEF. Product type: Ring, Teething, Non-Fluid Filled. Official classification: Class I. Official category: Dental. Regulation number: 872.5550. Implant flag: N. Life-sustain/support flag: N.

Official code: MEG. Product type: Syringe, Antistick. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. Implant flag: N. Life-sustain/support flag: N.

Official code: MEH. Product type: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3353. Implant flag: Y. Life-sustain/support flag: N.

Official code: MEQ. Product type: System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MER. Product type: Stent, Urethral, Prostatic, Permanent Or Semi-Permanent. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MES. Product type: Stent, Urethral, Bulbous, Permanent Or Semi-Permanent. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MFA. Product type: Device, Removal, Pacemaker Electrode, Percutaneous. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MFD. Product type: Cannula, Intrauterine Insemination. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5250. Implant flag: N. Life-sustain/support flag: N.

Official code: MFE. Product type: Agent, Injectable, Embolic. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MFJ. Product type: Device, Endoscopic Suturing. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: MFK. Product type: Lens, Multifocal Intraocular. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. Implant flag: Y. Life-sustain/support flag: N.

Official code: MFR. Product type: Stimulator, Brain, Implanted, For Behavior Modification. Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MFX. Product type: Vessel Guard Or Cover, To Facilitate Revision Surgeries. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3470. Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection. Implant flag: N. Life-sustain/support flag: N.

Official code: MFY. Product type: Endothelial Cell Harvesting Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4075. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: MGA. Product type: Alpha-1 Microglobulin, Antigen, Antiserum, Control. Official classification: Class I. Official category: Immunology. Regulation number: 866.5400. Implant flag: N. Life-sustain/support flag: N.

Official code: MGB. Product type: Device, Hemostasis, Vascular. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MGI. Product type: Aspirator, Ultrasonic. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MGM. Product type: C. Trachomatis (Chlamydia Group). Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: MGO. Product type: Closure, Wound, Adhesive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4018. Implant flag: N. Life-sustain/support flag: N.

Official code: MGP. Product type: Dressing, Wound And Burn, Occlusive. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MGQ. Product type: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MGR. Product type: Dressing, Wound And Burn, Interactive. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MGS. Product type: High Performance Liquid Chromatography For Cyclosporine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1235. Implant flag: N. Life-sustain/support flag: N.

Official code: MGU. Product type: Fluorescence Polarization Immunoassay For Cyclosporine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1235. Implant flag: N. Life-sustain/support flag: N.

Official code: MGV. Product type: Radioimmunoassay For Cyclosporine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1235. Implant flag: N. Life-sustain/support flag: N.

Official code: MGX. Product type: Test System, For Drugs Of Abuse. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MGZ. Product type: Valvulotome. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4885. Implant flag: N. Life-sustain/support flag: N.

Official code: MHC. Product type: Needle, Interosseous. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. Implant flag: Y. Life-sustain/support flag: N.

Official code: MHD. Product type: Pump, Infusion, Gallstone Dissolution. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: MHE. Product type: Implant, Auditory Brainstem. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MHI. Product type: Giardia Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: MHJ. Product type: Cryptosporidium Spp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: MHR. Product type: Test, Anti-Tumor Cell Susceptibility. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MHW. Product type: Dressing, Compression. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5075. Implant flag: N. Life-sustain/support flag: N.

Official code: MHX. Product type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1025. Implant flag: N. Life-sustain/support flag: N.

Official code: MHY. Product type: Stimulator, Electrical, Implanted, For Parkinsonian Tremor. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MHZ. Product type: Stimulator, Vestibular Acceleration, Therapeutic. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MIA. Product type: Needle, Spinal, Short Term. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: MIB. Product type: Elastomer, Silicone Block. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: MIC. Product type: Implant, Muscle, Pectoralis. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: MID. Product type: System, Test, Anticardiolipin Immunological. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MIE. Product type: Heart-Valve, Allograft. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MIF. Product type: Prothrombin Fragment 1.2. Official classification: Class II. Official category: Hematology. Regulation number: 864.7320. Implant flag: N. Life-sustain/support flag: N.

Official code: MIG. Product type: Strip, Test Isoniazid. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MIH. Product type: System, Endovascular Graft, Aortic Aneurysm Treatment. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MIJ. Product type: Needle, Tumor Localization. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: MIK. Product type: Device, Ultrasonic, Thermal Ablation. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MIP. Product type: Implanted Fecal Incontinence Device. Official classification: Class III. Official category: Unknown. PMA Approved: P010020 Implant flag: Y. Life-sustain/support flag: N.

Official code: MIR. Product type: Shunt, Portosystemic, Endoprosthesis. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MIU. Product type: Enzyme Linked Immunosorbent Assay, T. Cruzi. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: MIV. Product type: Immunofluorescent Assay, T. Cruzi. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: MIX. Product type: System, Vocal Cord Medialization. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Implant flag: Y. Life-sustain/support flag: N.

Official code: MIY. Product type: Enzyme Linked Immunosorbent Assay, Coccidioides Immitis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3135. Implant flag: N. Life-sustain/support flag: N.

Official code: MIZ. Product type: Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3320. Implant flag: N. Life-sustain/support flag: N.

Official code: MJA. Product type: Susceptibility Test Powders, Antimycobacterial. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: MJB. Product type: Antigen, Cancer 549. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MJC. Product type: Catheter, Urological (Antimicrobial) And Accessories. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Implant flag: N. Life-sustain/support flag: N.

Official code: MJD. Product type: Culture Media, Antimycobacteria, Susceptibility Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: MJE. Product type: Culture Media, Antifungal, Susceptibility Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1700. Implant flag: N. Life-sustain/support flag: N.

Official code: MJF. Product type: Check Valve, Retrograde Flow (In-Line). Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: MJG. Product type: Device, Percutaneous, Biopsy. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: MJH. Product type: Legionella, Spp., Elisa. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3300. Implant flag: N. Life-sustain/support flag: N.

Official code: MJI. Product type: Specimen/Tissue, Identification Orientation. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: MJJ. Product type: Cpb Check Valve, Retrograde Flow, In-Line. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: MJK. Product type: Dna Probe, Trichomonas Vaginalis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: MJL. Product type: Eia, Blastomyces Dermatitidis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3060. Implant flag: N. Life-sustain/support flag: N.

Official code: MJM. Product type: Dna Probe, Gardnerella Vaginalis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: MJN. Product type: Catheter, Intravascular Occluding, Temporary. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4450. Implant flag: N. Life-sustain/support flag: N.

Official code: MJO. Product type: Prosthesis, Intervertebral Disc. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MJP. Product type: Lens, Intraocular, Toric Optics. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. Implant flag: Y. Life-sustain/support flag: N.

Official code: MJS. Product type: Contrast Media, Ultrasound. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MJT. Product type: Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MJV. Product type: Device, Inflation, Middle Ear. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MJW. Product type: Prosthesis, Subtalar, Plug, Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: MJX. Product type: Kit, Serological, Positive Control. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: MJY. Product type: Kit, Serological, Negative Control. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: MJZ. Product type: Kit, Direct Antigen, Positive Control. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: MKA. Product type: Kit, Direct Antigen, Negative Control. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Implant flag: N. Life-sustain/support flag: N.

Official code: MKB. Product type: Device, Germicidal, Ultraviolet. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6500. Implant flag: N. Life-sustain/support flag: N.

Official code: MKD. Product type: Stimulator, Functional Walking Neuromuscular, Non-Invasive. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MKJ. Product type: Automated External Defibrillators (Non-Wearable). Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.5310. This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only. Implant flag: N. Life-sustain/support flag: N.

Official code: MKN. Product type: Catheter, Balloon, Transcervical. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MKO. Product type: Falloposcope. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1690. Implant flag: N. Life-sustain/support flag: N.

Official code: MKQ. Product type: Processor, Cervical Cytology Slide, Automated. Official classification: Class III. Official category: Unknown. It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist. Implant flag: N. Life-sustain/support flag: N.

Official code: MKT. Product type: Hepatitis Viral B Dna Detection. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3174. Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: MKU. Product type: Enzyme Immunoassay, Nicotine And Nicotine Metabolites. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: MKW. Product type: Cyclosporine. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1235. Implant flag: N. Life-sustain/support flag: N.

Official code: MKY. Product type: System, Skin Closure. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4320. Implant flag: N. Life-sustain/support flag: N.

Official code: MKZ. Product type: Dna Probe, Nucleic Acid Amplification, Chlamydia. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3120. Implant flag: N. Life-sustain/support flag: N.

Official code: MLA. Product type: Dna Probe, Yeast. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: MLC. Product type: Monitor, St Segment. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2340. Implant flag: N. Life-sustain/support flag: N.

Official code: MLD. Product type: Monitor, St Segment With Alarm. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1025. Implant flag: N. Life-sustain/support flag: N.

Official code: MLE. Product type: Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5110. Implant flag: N. Life-sustain/support flag: N.

Official code: MLH. Product type: Strip, Hama Igg, Elisa, In Vitro Test System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Implant flag: N. Life-sustain/support flag: N.

Official code: MLK. Product type: Thin Layer Chromatography, Tricyclic Antidepressant Drugs. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: MLL. Product type: Hemoglobin C (Abnormal Hemoglobin Variant). Official classification: Class II. Official category: Hematology. Regulation number: 864.7415. Implant flag: N. Life-sustain/support flag: N.

Official code: MLM. Product type: Enzyme Immunoassay, Tracrolimus. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1678. Implant flag: N. Life-sustain/support flag: N.

Official code: MLN. Product type: Electrode, Electrocardiograph, Multi-Function. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2360. Implant flag: N. Life-sustain/support flag: N.

Official code: MLO. Product type: Electrocardiograph, Ambulatory, With Analysis Algorithm. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: MLP. Product type: Keratoprosthesis, Temporary Implant, Surgical Use. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3400. Implant flag: Y. Life-sustain/support flag: N.

Official code: MLQ. Product type: Inhibitor, Peridural Fibrosis (Adhesion Barrier). Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MLR. Product type: Sterilizer, Chemical. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6860. Implant flag: N. Life-sustain/support flag: N.

Official code: MLS. Product type: Labor And Delivery Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: MLT. Product type: Pelvic Exam Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: MLV. Product type: Transcatheter Septal Occluder. Official classification: Class III. Official category: Unknown. Approved PMA: P000039 Implant flag: Y. Life-sustain/support flag: Y.

Official code: MLW. Product type: Warmer, Peritoneal Dialysate. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. Implant flag: N. Life-sustain/support flag: Y.

Official code: MLY. Product type: Vapocoolant Device. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MLZ. Product type: Vitrectomy, Instrument Cutter. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: MMA. Product type: Oximeter, Fetal Pulse. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MMC. Product type: Dilator, Expansive Iris (Accessory). Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: MMD. Product type: Toothbrush, Ionic, Battery-Powered. Official classification: Class I. Official category: Dental. Regulation number: 872.6865. Implant flag: N. Life-sustain/support flag: N.

Official code: MMF. Product type: Photorefractor. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1120. Implant flag: N. Life-sustain/support flag: N.

Official code: MMH. Product type: Blood Establishment Computer Software And Accessories. Official classification: Class II. Official category: Hematology. Regulation number: 864.9165. Implant flag: N. Life-sustain/support flag: N.

Official code: MMI. Product type: Immunoassay Method, Troponin Subunit. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: MMK. Product type: Container, Sharps. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: MML. Product type: Weights, Eyelid, External. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5700. Gravity assisted treatment of lagophthalmos (incomplete eyelid closure) Implant flag: N. Life-sustain/support flag: N.

Official code: MMO. Product type: Tray, Surgical, Ent. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Implant flag: N. Life-sustain/support flag: N.

Official code: MMP. Product type: Cover, Barrier, Protective. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: MMQ. Product type: Topographer, Corneal, Ac-Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1350. Implant flag: N. Life-sustain/support flag: N.

Official code: MMS. Product type: Lubricant, Vaginal, Patient. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6375. Implant flag: N. Life-sustain/support flag: N.

Official code: MMT. Product type: Resin, Root Canal Filling Containing Chloroform. Official classification: Class III. Official category: Dental. Regulation number: 872.3820. Implant flag: N. Life-sustain/support flag: N.

Official code: MMU. Product type: Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight. Official classification: Class III. Official category: Dental. Regulation number: 872.3400. Implant flag: N. Life-sustain/support flag: N.

Official code: MMW. Product type: System, Test, Tumor Marker, Monitoring, Bladder. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: MMX. Product type: Device, Percutaneous Retrieval. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5150. Implant flag: N. Life-sustain/support flag: N.

Official code: MMY. Product type: Lipoprotein, Low Density, Removal. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MMZ. Product type: Table, Cystometric, Electric. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4890. Implant flag: N. Life-sustain/support flag: N.

Official code: MNB. Product type: Device, Thermal Ablation, Endometrial. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MND. Product type: Ligator, Esophageal. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: MNE. Product type: Orthosis, Moldable, Supportive, Skin Protective. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Implant flag: N. Life-sustain/support flag: N.

Official code: MNF. Product type: Implant, Temporal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3550. Implant flag: Y. Life-sustain/support flag: N.

Official code: MNG. Product type: External Urethral Occluder, Urinary Incontinence-Control, Female. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5160. Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment. Implant flag: N. Life-sustain/support flag: N.

Official code: MNH. Product type: Orthosis, Spondylolisthesis Spinal Fixation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. Implant flag: Y. Life-sustain/support flag: N.

Official code: MNI. Product type: Orthosis, Spinal Pedicle Fixation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. Implant flag: Y. Life-sustain/support flag: N.

Official code: MNJ. Product type: Valve, Pressure Relief, Cardiopulmonary Bypass. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: MNK. Product type: Endoscopic Bite Block. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally. Implant flag: N. Life-sustain/support flag: N.

Official code: MNL. Product type: Accessories, Cleaning Brushes, For Endoscope. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: MNM. Product type: Reader, Cervical Cytology Slide, Automated. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MNO. Product type: System, Laser, Transmyocardial Revascularization. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MNQ. Product type: Stimulator, Hypoglossal Nerve, Implanted, Apnea. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MNR. Product type: Ventilatory Effort Recorder. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2375. Implant flag: N. Life-sustain/support flag: N.

Official code: MNS. Product type: Ventilator, Continuous, Non-Life-Supporting. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. Implant flag: N. Life-sustain/support flag: N.

Official code: MNT. Product type: Sv70 Ventilator. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. Implant flag: N. Life-sustain/support flag: Y.

Official code: MNU. Product type: Staple, Absorbable. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: MNV. Product type: Strip, Dialysate Ph Indicator. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: MNW. Product type: Analyzer, Body Composition. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. Implant flag: N. Life-sustain/support flag: N.

Official code: MOA. Product type: Analyzer, Diagnostic, Fiber Optic (Colon). Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MOB. Product type: Test System, Antineutrophil Cytoplasmic Antibodies (Anca). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MOC. Product type: Cushion, Flotation, Therapeutic. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5170. Implant flag: N. Life-sustain/support flag: N.

Official code: MOD. Product type: Accessory To Continuous Ventilator (Respirator). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. Implant flag: N. Life-sustain/support flag: N.

Official code: MOE. Product type: Collagen Corneal Shield. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4750. Implant flag: N. Life-sustain/support flag: N.

Official code: MOF. Product type: Guide, Wire, Catheter, Neurovasculature. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1330. Implant flag: N. Life-sustain/support flag: N.

Official code: MOH. Product type: Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2730. Implant flag: N. Life-sustain/support flag: N.

Official code: MOI. Product type: System, Test, Immunological, Antigen, Tumor. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: MOJ. Product type: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: MOK. Product type: Vaginoscope And Accessories. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1630. Implant flag: N. Life-sustain/support flag: N.

Official code: MOL. Product type: Condom, Synthetic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: MOM. Product type: System, Hemodynamic, Implantable. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MON. Product type: System, Hemodialysis, Remote Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: N.

Official code: MOP. Product type: Rotator, Prosthetic Heart Valve. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3935. Implant flag: N. Life-sustain/support flag: N.

Official code: MOQ. Product type: Battery, Replacement, Rechargeable. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Implant flag: N. Life-sustain/support flag: N.

Official code: MOS. Product type: Coil, Magnetic Resonance, Specialty. Official classification: Class II. Official category: Radiology. Regulation number: 892.1000. Implant flag: N. Life-sustain/support flag: N.

Official code: MOT. Product type: Irradiator, Blood To Prevent Graft Versus Host Disease. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MOU. Product type: Intravascular Radiation Delivery System. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MOV. Product type: Catheters, Salpingography. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: MOZ. Product type: Acid, Hyaluronic, Intraarticular. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MPA. Product type: Endoilluminator. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: MPB. Product type: Catheter, Hemodialysis, Non-Implanted. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: N. Life-sustain/support flag: Y.

Official code: MPC. Product type: Atrial Defibrillator. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.5300. Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MPD. Product type: Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5300. Implant flag: N. Life-sustain/support flag: Y.

Official code: MPE. Product type: Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5550. Implant flag: N. Life-sustain/support flag: Y.

Official code: MPG. Product type: Urinary Carbohydrate Analysis Kit. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1505. Implant flag: N. Life-sustain/support flag: N.

Official code: MPI. Product type: Glenoid Fossa Prosthesis. Official classification: Class III. Official category: Dental. Regulation number: 872.3950. Implant flag: Y. Life-sustain/support flag: N.

Official code: MPJ. Product type: Interarticular Disc Prosthesis (Interpositional Implant). Official classification: Class III. Official category: Dental. Regulation number: 872.3970. Implant flag: Y. Life-sustain/support flag: N.

Official code: MPK. Product type: Semi-Constrained Metal/Polymer Finger Joint Prosthesis. Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MPL. Product type: Mandibular Condyle Prosthesis. Official classification: Class III. Official category: Dental. Regulation number: 872.3960. PMA to be filed by 3/30/99 (63 FR 71746 (12/30/98)) Implant flag: Y. Life-sustain/support flag: N.

Official code: MPN. Product type: Tissue Adhesive For The Topical Approximation Of Skin. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4010. Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k). Implant flag: N. Life-sustain/support flag: N.

Official code: MPO. Product type: Infant Heel Warmer (Chemical Heat Pack). Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5710. Implant flag: N. Life-sustain/support flag: N.

Official code: MPQ. Product type: Container, Specimen, Urine, Drugs Of Abuse, Over The Counter. Official classification: Class I. Official category: Pathology. Regulation number: 864.3260. Implant flag: N. Life-sustain/support flag: N.

Official code: MPR. Product type: Stent, Bladder, Fetal. Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MPT. Product type: Contraception Calculator. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5350. Implant flag: N. Life-sustain/support flag: N.

Official code: MPU. Product type: Source, Chemiluminescent Light. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: MPV. Product type: Implant, Hearing, Active, Middle Ear, Partially Implanted. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MPW. Product type: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction. Official classification: Class III. Official category: Unknown. Pma approved: P000054 Implant flag: Y. Life-sustain/support flag: N.

Official code: MQA. Product type: Anti-Ribosomal P Antibodies. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Implant flag: N. Life-sustain/support flag: N.

Official code: MQB. Product type: Solid State X-Ray Imager (Flat Panel/Digital Imager). Official classification: Class II. Official category: Radiology. Regulation number: 892.1680. Implant flag: N. Life-sustain/support flag: N.

Official code: MQC. Product type: Mouthguard, Prescription. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MQE. Product type: Needle, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6100. Implant flag: N. Life-sustain/support flag: N.

Official code: MQF. Product type: Catheter, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6110. Implant flag: N. Life-sustain/support flag: N.

Official code: MQG. Product type: Accessory, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6120. Implant flag: N. Life-sustain/support flag: N.

Official code: MQH. Product type: Microtools, Assisted Reproduction (Pipettes). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6130. Implant flag: N. Life-sustain/support flag: N.

Official code: MQI. Product type: Microtool Fabrication, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6140. Implant flag: N. Life-sustain/support flag: N.

Official code: MQJ. Product type: Micromanipulators And Microinjectors, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6150. Implant flag: N. Life-sustain/support flag: N.

Official code: MQK. Product type: Labware, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6160. Implant flag: N. Life-sustain/support flag: N.

Official code: MQL. Product type: Media, Reproductive. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6180. Implant flag: N. Life-sustain/support flag: N.

Official code: MQM. Product type: Bilirubin (Total And Unbound) In The Neonate Test System. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1113. Implant flag: N. Life-sustain/support flag: N.

Official code: MQN. Product type: External Mandibular Fixator And/Or Distractor. Official classification: Class II. Official category: Dental. Regulation number: 872.4760. Implant flag: Y. Life-sustain/support flag: N.

Official code: MQO. Product type: Prosthetic Disc Nucleus Device. Official classification: Not classified. Official category: Unknown. Export only Implant flag: Y. Life-sustain/support flag: N.

Official code: MQP. Product type: Spinal Vertebral Body Replacement Device. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Implant flag: Y. Life-sustain/support flag: N.

Official code: MQR. Product type: Stent, Colonic, Metallic, Expandable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3610. Implant flag: Y. Life-sustain/support flag: N.

Official code: MQS. Product type: System, Hemodialysis, Access Recirculation Monitoring. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: MQT. Product type: Pump, Drug Administration, Closed Loop. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MQU. Product type: Ocular Peg. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3320. Implant flag: Y. Life-sustain/support flag: N.

Official code: MQV. Product type: Filler, Bone Void, Calcium Compound. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3045. Implant flag: Y. Life-sustain/support flag: N.

Official code: MQW. Product type: Transilluminator, Fiber Optic. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: MQX. Product type: Needle, Acupuncture, Single Use. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5580. Implant flag: N. Life-sustain/support flag: N.

Official code: MQZ. Product type: Prosthesis, Nail. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MRA. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MRB. Product type: Indicator, Biological, Liquid Chemical Sterilization Process. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: MRC. Product type: Products, Contact Lens Care, Rigid Gas Permeable. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5918. Implant flag: N. Life-sustain/support flag: N.

Official code: MRD. Product type: Mammary Sizer. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MRE. Product type: Solution, Sodium Hyaluronate. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MRG. Product type: System, Test, Vitamin D. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1825. Implant flag: N. Life-sustain/support flag: N.

Official code: MRH. Product type: Pump, Infusion, Ophthalmic. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: MRI. Product type: Orthosis, Truncal/Orthosis, Limb. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Implant flag: N. Life-sustain/support flag: N.

Official code: MRJ. Product type: Ring, Endocapsular. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MRK. Product type: System, Imaging, Fluorescence. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MRL. Product type: Scale, Sponge, Surgical, Electrically-Powered. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2740. Implant flag: N. Life-sustain/support flag: N.

Official code: MRM. Product type: Defibrillator, Implantable, Dual-Chamber. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MRN. Product type: Apparatus, Nitric Oxide Delivery. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5165. Implant flag: N. Life-sustain/support flag: Y.

Official code: MRO. Product type: Apparatus, Nitric Oxide, Backup Delivery. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5165. Implant flag: N. Life-sustain/support flag: Y.

Official code: MRP. Product type: Analyzer, Nitric Oxide. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2380. Implant flag: N. Life-sustain/support flag: N.

Official code: MRQ. Product type: Analyzer, Nitrogen Dioxide. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2385. Implant flag: N. Life-sustain/support flag: Y.

Official code: MRR. Product type: System, Test, Low Density, Lipoprotein. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: MRS. Product type: Test System, Nicotine, Cotinine, Metabolites. Official classification: Class I. Official category: Clinical Toxicology. Regulation number: 862.3220. Implant flag: N. Life-sustain/support flag: N.

Official code: MRU. Product type: Implanted Subcortical Electrical Stimulator (Motor Disorders). Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MRV. Product type: Drink, Glucose Tolerance. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: MRW. Product type: System, Facet Screw Spinal Device. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MRX. Product type: System, Assisted Reproduction Laser. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6200. This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology. Implant flag: N. Life-sustain/support flag: N.

Official code: MRY. Product type: Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: MRZ. Product type: Accessories, Pump, Infusion. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Implant flag: N. Life-sustain/support flag: N.

Official code: MSA. Product type: Dressing, Wound And Burn, Occlusive, Heated. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4020. Implant flag: N. Life-sustain/support flag: N.

Official code: MSB. Product type: System And Accessories, Isolated Heart, Transport And Preservation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5880. Implant flag: N. Life-sustain/support flag: N.

Official code: MSC. Product type: Barrier, Std, Oral Sex. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. Implant flag: N. Life-sustain/support flag: N.

Official code: MSD. Product type: Catheter, Hemodialysis, Implanted. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MSE. Product type: Hemodialyzer, Re-Use, Low Flux. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Implant flag: N. Life-sustain/support flag: Y.

Official code: MSF. Product type: Hemodialyzer, Re-Use, High Flux. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5860. Implant flag: N. Life-sustain/support flag: Y.

Official code: MSG. Product type: Ophthalmoscopes, Replacement Batteries, Hand-Held. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: MSH. Product type: Respirator, Surgical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1). Implant flag: N. Life-sustain/support flag: N.

Official code: MSI. Product type: Solution, Cleaning / Lubricating, Artificial Eye. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MSJ. Product type: Apolipoproteins. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: MSK. Product type: Immunoassay For Blood Tacrolimus. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: Y.

Official code: MSL. Product type: System, Test, Topiramatee. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Implant flag: N. Life-sustain/support flag: N.

Official code: MSM. Product type: System, Test, Lipoprotein(A). Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. Implant flag: N. Life-sustain/support flag: N.

Official code: MSQ. Product type: Test, Urea (Breath Or Blood). Official classification: Class I. Official category: Microbiology. Regulation number: 866.3110. Implant flag: N. Life-sustain/support flag: N.

Official code: MSR. Product type: Tubing, Replacement, Phacofragmentation Unit. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4150. Implant flag: N. Life-sustain/support flag: N.

Official code: MSS. Product type: Folders And Injectors, Intraocular Lens (Iol). Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: MST. Product type: Antibodies, Gliadin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5750. Implant flag: N. Life-sustain/support flag: N.

Official code: MSV. Product type: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MSW. Product type: System, Test, Thyroglobulin. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: MSX. Product type: System, Network And Communication, Physiological Monitors. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2300. Implant flag: N. Life-sustain/support flag: Y.

Official code: MSY. Product type: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5665. Implant flag: N. Life-sustain/support flag: Y.

Official code: MSZ. Product type: Strip, Test, Reagent, Residuals For Dialysate. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5665. Implant flag: N. Life-sustain/support flag: Y.

Official code: MTA. Product type: Lens, Intraocular, Phakic. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MTC. Product type: Indicator, Chemical, Enzymatic, Sterilization Process. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: MTD. Product type: Catheter, Intracardiac Mapping, High-Density Array. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1220. Implant flag: N. Life-sustain/support flag: N.

Official code: MTE. Product type: System, Pacing, Temporary, Acute, Internal Atrial Defibrillation. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: Y.

Official code: MTF. Product type: Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTG. Product type: Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTH. Product type: Tray, Leukocyte Typing. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTI. Product type: Kit, Cell Screening, Fetal. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTJ. Product type: Wax, Bone. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MTK. Product type: Kit, Sample Collection, Hiv. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTL. Product type: Monitor,Test,Hiv-1. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTN. Product type: Test, Syphilis, Treponemal. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTO. Product type: Software, Management, Microplate Assay. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTP. Product type: Antibody To Htlv-1, Elisa. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: Y.

Official code: MTQ. Product type: Software, Blood Virus Applications. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTR. Product type: Progenitor Cell Enumeration. Official classification: Class II. Official category: Unknown. Cber Implant flag: N. Life-sustain/support flag: N.

Official code: MTS. Product type: Vials, Challenge, Endotoxin. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MTV. Product type: Sharps Needle Destruction Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6210. A prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means. Implant flag: N. Life-sustain/support flag: N.

Official code: MTW. Product type: System, Water, Reproduction, Assisted, And Purification. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6170. Implant flag: N. Life-sustain/support flag: N.

Official code: MTX. Product type: Microscope And Microscope Accessories, Reproduction, Assisted. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.6190. Implant flag: N. Life-sustain/support flag: N.

Official code: MTZ. Product type: Wrap, Implant, Orbital. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3320. Implant flag: Y. Life-sustain/support flag: N.

Official code: MUA. Product type: Bone Sonometer. Official classification: Class II. Official category: Radiology. Regulation number: 892.1180. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal. Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers Implant flag: N. Life-sustain/support flag: N.

Official code: MUD. Product type: Oximeter, Tissue Saturation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Implant flag: N. Life-sustain/support flag: N.

Official code: MUE. Product type: Full Field Digital, System, X-Ray, Mammographic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1715. Implant flag: N. Life-sustain/support flag: N.

Official code: MUH. Product type: System, X-Ray, Extraoral Source, Digital. Official classification: Class II. Official category: Dental. Regulation number: 872.1800. Implant flag: N. Life-sustain/support flag: N.

Official code: MUI. Product type: Media, Coupling, Ultrasound. Official classification: Class II. Official category: Radiology. Regulation number: 892.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: MUJ. Product type: System, Planning, Radiation Therapy Treatment. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: MUK. Product type: Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence Implant flag: N. Life-sustain/support flag: N.

Official code: MUL. Product type: Generator, Electrosurgical, Coagulation, Cancer. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: MUM. Product type: Stent, Metallic, Expandable, Duodenal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3610. Implant flag: Y. Life-sustain/support flag: N.

Official code: MUQ. Product type: Glue, Surgical, Arteries. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MUR. Product type: Graft, Sclera, Reinforcement. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MUS. Product type: Fluidic, Phacoemulsification/Phacofragmentation. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4670. Implant flag: N. Life-sustain/support flag: N.

Official code: MUT. Product type: Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer). Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: MUU. Product type: System, Suction, Lipoplasty. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5040. See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881). Implant flag: N. Life-sustain/support flag: N.

Official code: MUW. Product type: Lens, Contact (Orthokeratology). Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5916. Implant flag: N. Life-sustain/support flag: N.

Official code: MUZ. Product type: Stimulator, Autonomic Nerve, Implanted (Depression). Official classification: Class III. Official category: Unknown. The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Implant flag: Y. Life-sustain/support flag: N.

Official code: MVA. Product type: Orthosis, Cranial. Official classification: Class II. Official category: Neurology. Regulation number: 882.5970. Implant flag: N. Life-sustain/support flag: N.

Official code: MVC. Product type: System, Test, Her-2/Neu, Ihc. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVD. Product type: System, Test, Her-2/Neu, Nucleic Acid Or Serum. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVE. Product type: Biosensor, Immunoassay, Myoglobin. Official classification: Class II. Official category: Immunology. Regulation number: 866.5680. Implant flag: N. Life-sustain/support flag: N.

Official code: MVF. Product type: System, Laser, Photodynamic Therapy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVG. Product type: System, Laser, Fiber Optic, Photodynamic Therapy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVH. Product type: Device, Detection, Sulfide. Official classification: Class II. Official category: Dental. Regulation number: 872.1870. Implant flag: N. Life-sustain/support flag: N.

Official code: MVJ. Product type: Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MVK. Product type: Wearable Automated External Defibrillator. Official classification: Class III. Official category: Unknown. The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician. Implant flag: N. Life-sustain/support flag: Y.

Official code: MVL. Product type: Cord, Retraction. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVM. Product type: Autoantibodies, Endomysial(Tissue Transglutaminase). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MVN. Product type: Lens, Contact, (Disposable). Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: MVO. Product type: Kit, Test, Multiple, Drugs Of Abuse, Over The Counter. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVR. Product type: Device, Anastomotic, Microvascular. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Implant flag: Y. Life-sustain/support flag: N.

Official code: MVS. Product type: Kit, Typing, Hla-Dqb. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MVU. Product type: Reagents, Specific, Analyte. Official classification: Class I. Official category: Pathology. Regulation number: 864.4020. Implant flag: N. Life-sustain/support flag: N.

Official code: MVV. Product type: Device, Acupressure. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVW. Product type: Kit, Western Blot, Hiv-1. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVX. Product type: Antibody, Monoclonal Blocking, Hiv-1. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVY. Product type: Monoclonal, Hiv-1. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MVZ. Product type: System, Test, Home, Hiv-1. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MWA. Product type: System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3372. intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: MWB. Product type: Kit, Test, Saliva, Hiv-1&2. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MWD. Product type: Electrosurgical, Radio Frequency, Refractive Correction. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MWG. Product type: System, Oxygen, Aqueous. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MWH. Product type: Pulmonic Valved Conduit. Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MWI. Product type: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2300. Implant flag: N. Life-sustain/support flag: N.

Official code: MWJ. Product type: Electrocardiograph, Ambulatory (Without Analysis). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2800. Implant flag: N. Life-sustain/support flag: N.

Official code: MWL. Product type: Lens, Contact (Rigid Gas Permeable), Extended Wear. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.5916. Implant flag: N. Life-sustain/support flag: N.

Official code: MWM. Product type: Sensor, Electro-Optical (For Cervical Cancer). Official classification: Class III. Official category: Unknown. An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells. Implant flag: N. Life-sustain/support flag: N.

Official code: MWO. Product type: Reagent, Blood Bank, Quality Control. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MWP. Product type: Cabinet, X-Ray System. Official classification: Class II. Official category: Radiology. Regulation number: 892.1680. Implant flag: N. Life-sustain/support flag: N.

Official code: MWQ. Product type: System, Test, Total Antioxidant Status. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MWS. Product type: Stabilizer, Heart. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.4500. Implant flag: N. Life-sustain/support flag: N.

Official code: MWW. Product type: Accessory - Film Dosimetry System. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Implant flag: N. Life-sustain/support flag: N.

Official code: MWY. Product type: System, Microwave, Hair Removal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: MWZ. Product type: Expander, Breast, External. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: MXA. Product type: System, Test, Breath Nitric Oxide. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3080. Implant flag: N. Life-sustain/support flag: N.

Official code: MXB. Product type: Test, Vaginal, Bacterial Sialidase. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Implant flag: N. Life-sustain/support flag: N.

Official code: MXC. Product type: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2800. Implant flag: Y. Life-sustain/support flag: N.

Official code: MXD. Product type: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1025. Implant flag: Y. Life-sustain/support flag: N.

Official code: MXF. Product type: System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. Implant flag: N. Life-sustain/support flag: N.

Official code: MXG. Product type: Lamp, Uvc, (For Treating Skin And Wounds). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4630. Implant flag: N. Life-sustain/support flag: N.

Official code: MXJ. Product type: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: MXK. Product type: Device, Analysis, Anterior Segment. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1850. Implant flag: N. Life-sustain/support flag: N.

Official code: MXM. Product type: Cap, Cooling (Infants). Official classification: Class III. Official category: Unknown. Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*. Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. Implant flag: N. Life-sustain/support flag: N.

Official code: MXO. Product type: Laser, System, Phacolysis. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4670. Implant flag: N. Life-sustain/support flag: N.

Official code: MXP. Product type: Bone Particle Collector. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4800. Implant flag: N. Life-sustain/support flag: N.

Official code: MXQ. Product type: Stent, Urethral, External Sphincter, Permanent. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: MXT. Product type: Device, Accessory, Cooling Plate For Tissue Embedding Station. Official classification: Class I. Official category: Pathology. Regulation number: 864.3010. Implant flag: N. Life-sustain/support flag: N.

Official code: MXW. Product type: Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5010. Implant flag: Y. Life-sustain/support flag: N.

Official code: MXY. Product type: Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: MXZ. Product type: Immunohistochemistry Assay, Antibody, Progesterone Receptor. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: MYA. Product type: Immunohistochemistry Antibody Assay, Estrogen Receptor. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: MYB. Product type: Pillow, Cervical (For Mild Sleep Apnea). Official classification: Class II. Official category: Dental. Regulation number: 872.5570. Implant flag: N. Life-sustain/support flag: N.

Official code: MYC. Product type: Ophthalmoscope, Laser, Scanning. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1570. Implant flag: N. Life-sustain/support flag: N.

Official code: MYD. Product type: Keratome, Water Jet. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4370. Implant flag: N. Life-sustain/support flag: N.

Official code: MYE. Product type: System, Electrogastrography (Egg). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1735. Implant flag: N. Life-sustain/support flag: N.

Official code: MYF. Product type: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. Implant flag: N. Life-sustain/support flag: N.

Official code: MYH. Product type: System, Non-Coherent Light, Photodynamic Therapy. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYI. Product type: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Implant flag: N. Life-sustain/support flag: N.

Official code: MYJ. Product type: Device, Mixing And Weighing, Semi-Automated. Official classification: Class II. Official category: Hematology. Regulation number: 864.9195. Implant flag: N. Life-sustain/support flag: N.

Official code: MYK. Product type: Kit, Cord Blood Collection. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYL. Product type: Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYM. Product type: Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYN. Product type: Analyzer, Medical Image. Official classification: Class II. Official category: Radiology. Regulation number: 892.2070. For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers Implant flag: N. Life-sustain/support flag: N.

Official code: MYP. Product type: Test, Platelet Antibody. Official classification: Class II. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYR. Product type: Test, Donor, Syphilis, Antigens, Treponemal. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3830. Implant flag: N. Life-sustain/support flag: N.

Official code: MYS. Product type: Device, Ahf, Automated Cryoprecipitation. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYT. Product type: Biosensor, Immunoassay, Cpk Or Isoenzymes. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. Implant flag: N. Life-sustain/support flag: N.

Official code: MYU. Product type: Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty. Official classification: Class II. Official category: Neurology. Regulation number: 882.5300. Implant flag: Y. Life-sustain/support flag: N.

Official code: MYW. Product type: Irradiation, Blood Indicators. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYX. Product type: System, Blood Collection, Vacuum-Assisted, Automated. Official classification: Class I. Official category: Hematology. Regulation number: 864.9125. Implant flag: N. Life-sustain/support flag: N.

Official code: MYY. Product type: Separator, Semi-Automated, Blood Component. Official classification: Class I. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MYZ. Product type: Kit, Test (Donors), For Bloodborne Pathogen. Official classification: Class II. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZA. Product type: Test, Equipment, Automated Bloodborne Pathogen. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZC. Product type: System, Detection, Bacterial, For Platelet Transfusion Products. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2560. Implant flag: N. Life-sustain/support flag: N.

Official code: MZD. Product type: System, In-Office Tinting, Contact Lenses. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: MZE. Product type: Test, Donor, Cmv. Official classification: Class II. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZF. Product type: Test, Hiv Detection. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3956. Implant flag: N. Life-sustain/support flag: N.

Official code: MZG. Product type: Test, Residual, Wbc In Leukoreduced Blood. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. CBER Implant flag: N. Life-sustain/support flag: N.

Official code: MZH. Product type: Test, Quantitative, For Hla, Non-Diagnostic. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZI. Product type: Test, Qualitative, For Hla, Non-Diagnostic. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZK. Product type: System, Separation, Hematopoietic Stem Cell. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZL. Product type: Kit, Test, Quality Control For Endotoxin. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: MZM. Product type: Fibrin Sealant Preparation Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. Implant flag: N. Life-sustain/support flag: N.

Official code: MZO. Product type: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3169. Implant flag: N. Life-sustain/support flag: N.

Official code: MZP. Product type: Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3170. Implant flag: N. Life-sustain/support flag: N.

Official code: MZQ. Product type: Balloon, Detachable, For Neurovascular Occlusion. Official classification: Class II. Official category: Neurology. Regulation number: 882.5950. Implant flag: Y. Life-sustain/support flag: Y.

Official code: MZR. Product type: Topical Approximation System. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5240. Implant flag: N. Life-sustain/support flag: N.

Official code: MZT. Product type: Device, Heimlich Maneuver Assist. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5115. Implant flag: N. Life-sustain/support flag: Y.

Official code: MZU. Product type: System, Test, Sodium, Enzymatic Method. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1665. Implant flag: N. Life-sustain/support flag: N.

Official code: MZV. Product type: Test, System, Potassium, Enzymatic Method. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1600. Implant flag: N. Life-sustain/support flag: N.

Official code: MZW. Product type: Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief. Official classification: Class II. Official category: Dental. Regulation number: 872.3275. Implant flag: N. Life-sustain/support flag: N.

Official code: MZY. Product type: Graft, Vascular, Stainless Steel Tunneler. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3450. Implant flag: N. Life-sustain/support flag: N.

Official code: NAA. Product type: Lens, Intraocular, Accommodative. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. Implant flag: Y. Life-sustain/support flag: N.

Official code: NAB. Product type: Gauze / Sponge,Nonresorbable For External Use. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. Implant flag: N. Life-sustain/support flag: N.

Official code: NAC. Product type: Dressing, Wound, Hydrophilic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4018. Implant flag: N. Life-sustain/support flag: N.

Official code: NAD. Product type: Dressing, Wound, Occlusive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4020. Implant flag: N. Life-sustain/support flag: N.

Official code: NAE. Product type: Dressing, Wound, Hydrogel Without Drug And/Or Biologic. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4022. Implant flag: N. Life-sustain/support flag: N.

Official code: NAF. Product type: Antigen(Complexed),Prostate Specific,(Cpsa). Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NAH. Product type: System, Test, Tumor Marker, For Detection Of Bladder Cancer. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NAI. Product type: Lens, Prescription, Color Deficiency. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5844. Implant flag: N. Life-sustain/support flag: N.

Official code: NAJ. Product type: Agents, Embolic, For Treatment Of Uterine Fibroids. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3300. Implant flag: Y. Life-sustain/support flag: N.

Official code: NAK. Product type: System, Test, Biotinidase. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1118. Implant flag: N. Life-sustain/support flag: N.

Official code: NAL. Product type: Test, Immunoassay, Biosensor, Hcg. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1155. Implant flag: N. Life-sustain/support flag: N.

Official code: NAM. Product type: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5310. Implant flag: N. Life-sustain/support flag: N.

Official code: NAN. Product type: Tester, Acoustic, Bone Quality. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NAO. Product type: Test, Carbohydrate Deficient Transferrin. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1360. Implant flag: N. Life-sustain/support flag: N.

Official code: NAP. Product type: Cardiac Support Mesh Wrap. Official classification: Not classified. Official category: Unknown. The device is a passive mesh wrap that is placed around both ventricles of the heart; The intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium. The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate. Implant flag: Y. Life-sustain/support flag: N.

Official code: NAQ. Product type: Lipoprotein, High Density, Hdl, Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: NAS. Product type: Tympanometer. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1090. Implant flag: N. Life-sustain/support flag: N.

Official code: NAV. Product type: Graft, Bypass, Coronary Artery. Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NAW. Product type: Microspheres Radionuclide. Official classification: Class III. Official category: Unknown. Approved PMA: P990065 Implant flag: Y. Life-sustain/support flag: N.

Official code: NAY. Product type: System, Surgical, Computer Controlled Instrument. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NAZ. Product type: Stimulator, Bladder. Official classification: HDE. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NBC. Product type: Test, Natriuretic Peptide. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1117. Implant flag: N. Life-sustain/support flag: N.

Official code: NBE. Product type: Sealant, Polymerizing. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: NBF. Product type: Prosthesis, Retinal. Official classification: HDE. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: NBG. Product type: Marker, Colon. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: NBH. Product type: Accessories, Arthroscopic. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: NBK. Product type: System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. Implant flag: N. Life-sustain/support flag: N.

Official code: NBL. Product type: Light-Induced Fluorescence Caries Detector. Official classification: Class II. Official category: Dental. Regulation number: 872.1745. Implant flag: N. Life-sustain/support flag: N.

Official code: NBN. Product type: Generator, Shock-Wave, For Pain Relief. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NBO. Product type: Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: NBS. Product type: Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Implant flag: N. Life-sustain/support flag: N.

Official code: NBT. Product type: Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae). Official classification: Class II. Official category: Immunology. Regulation number: 866.5785. Implant flag: N. Life-sustain/support flag: N.

Official code: NBV. Product type: Device, Engorgement, Clitoral. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5970. Implant flag: N. Life-sustain/support flag: N.

Official code: NBW. Product type: System, Test, Blood Glucose, Over The Counter. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Implant flag: N. Life-sustain/support flag: N.

Official code: NBY. Product type: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5035. Implant flag: Y. Life-sustain/support flag: N.

Official code: NBZ. Product type: Clamp And Cutter, Umbilical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Implant flag: N. Life-sustain/support flag: N.

Official code: NCA. Product type: Clip, Implantable, For Coronary Artery Bypass Graft (Cabg). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Implant flag: Y. Life-sustain/support flag: N.

Official code: NCB. Product type: Weights, Eyelid, Implantable. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5700. Gravity assisted treatment of lagophthalmos (incomplete eyelid closure) Implant flag: Y. Life-sustain/support flag: N.

Official code: NCD. Product type: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NCE. Product type: Injector, Capsular Tension Ring. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4300. Implant flag: N. Life-sustain/support flag: N.

Official code: NCF. Product type: Aberrometer, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1760. Implant flag: N. Life-sustain/support flag: N.

Official code: NCG. Product type: Neuropsychiatric Interpretative Electroencephalograph Assessment Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.1440. Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis." Implant flag: N. Life-sustain/support flag: N.

Official code: NCJ. Product type: Telescope, Implantable, Miniature. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: NCK. Product type: Button, Iris, Eye, Artificial. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.3200. Implant flag: N. Life-sustain/support flag: N.

Official code: NCL. Product type: Imager, Breast, Electrical Impedance. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NCO. Product type: Implant, Cartilage, For Articular Cartilage Repair. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: NCR. Product type: Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4100. Implant flag: N. Life-sustain/support flag: N.

Official code: NCS. Product type: System, Imaging, Holography, Acoustic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1550. Implant flag: N. Life-sustain/support flag: N.

Official code: NCT. Product type: Instrument, Glucose, Noninvasive Technology. Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NCV. Product type: Lithotripter, Shockwave (For Treating Gallbladder Stones). Official classification: Class III. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NCW. Product type: System, Test, Her-2/Neu, Monitoring. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. Implant flag: N. Life-sustain/support flag: N.

Official code: NCX. Product type: System, Hypothermia, Intravenous, Cooling. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5900. Implant flag: N. Life-sustain/support flag: N.

Official code: NCZ. Product type: Lens, Contact, For Color Vision Deficiency. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5925. Implant flag: N. Life-sustain/support flag: N.

Official code: NDA. Product type: Helmet, Cranial, For Protective Use. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. Implant flag: N. Life-sustain/support flag: N.

Official code: NDC. Product type: Calculator, Drug Dose. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1890. Implant flag: N. Life-sustain/support flag: N.

Official code: NDD. Product type: Cerclage, Fixation, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3010. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDE. Product type: Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3020. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDF. Product type: Plate, Fixation, Bone, Non-Spinal, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDG. Product type: Washer, Bolt, Nut, Non-Spinal, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDH. Product type: Nail, Fixation, Bone, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDI. Product type: Staple, Fixation, Bone, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDJ. Product type: Screw, Fixation, Bone, Non-Spinal, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDK. Product type: System, External Fixator (With Metallic Invasive Components). Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDL. Product type: Pin, Fixation, Smooth, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDM. Product type: Pin, Fixation, Threaded, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDN. Product type: Cement, Bone, Vertebroplasty. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. Implant flag: Y. Life-sustain/support flag: N.

Official code: NDP. Product type: Accessories, Implant, Dental, Endosseous. Official classification: Class I. Official category: Dental. Regulation number: 872.3980. Implant flag: N. Life-sustain/support flag: N.

Official code: NDQ. Product type: System, Catheter Or Guidewire, Steerable (Magnetic). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1290. Implant flag: N. Life-sustain/support flag: N.

Official code: NDR. Product type: Enzyme Immunoassay, Inhibin-A. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1260. Implant flag: N. Life-sustain/support flag: N.

Official code: NDS. Product type: Media, Culture, Ex Vivo, Tissue And Cell. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5885. Implant flag: N. Life-sustain/support flag: N.

Official code: NDV. Product type: Test, Ecarin Clotting Time (Ect). Official classification: HDE. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NDW. Product type: Assay, Porphyrin, Spectrophotometry, Lithium. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3560. Implant flag: N. Life-sustain/support flag: N.

Official code: NDY. Product type: Test, Cystatin C. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1225. Implant flag: N. Life-sustain/support flag: N.

Official code: NDZ. Product type: Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3370. Implant flag: N. Life-sustain/support flag: N.

Official code: NEA. Product type: Cement, Ear, Nose And Throat. Official classification: Class II. Official category: Dental. Regulation number: 872.3275. Implant flag: Y. Life-sustain/support flag: N.

Official code: NEC. Product type: Bandage, Liquid, Skin Protectant. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5090. Implant flag: N. Life-sustain/support flag: N.

Official code: NEG. Product type: Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis. Official classification: Class III. Official category: Unknown. Pma approved: P000057 Implant flag: Y. Life-sustain/support flag: N.

Official code: NEH. Product type: Anchor, Fascial. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Implant flag: Y. Life-sustain/support flag: N.

Official code: NEI. Product type: Prosthesis, Condyle, Mandibular, Temporary. Official classification: Class II. Official category: Dental. Regulation number: 872.4770. Implant flag: Y. Life-sustain/support flag: N.

Official code: NEJ. Product type: System, Cryosurgical, Liquid Nitrogen, For Gastroenterology. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4350. Implant flag: N. Life-sustain/support flag: N.

Official code: NEK. Product type: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: NEO. Product type: System, Test, Osteocalcin. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1050. Implant flag: N. Life-sustain/support flag: N.

Official code: NEP. Product type: System/Device, Pharmacy Compounding. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Implant flag: N. Life-sustain/support flag: N.

Official code: NEQ. Product type: Device, Telemedicine, Robotic. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: NEU. Product type: Marker, Radiographic, Implantable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Implant flag: Y. Life-sustain/support flag: N.

Official code: NEW. Product type: Suture, Surgical, Absorbable, Polydioxanone. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4840. Implant flag: Y. Life-sustain/support flag: N.

Official code: NEY. Product type: System, Ablation, Microwave And Accessories. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Implant flag: N. Life-sustain/support flag: N.

Official code: NEZ. Product type: System, Imaging, Gastrointestinal, Wireless, Capsule. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: NFA. Product type: Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Implant flag: N. Life-sustain/support flag: N.

Official code: NFB. Product type: Conserver, Oxygen. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5905. Implant flag: N. Life-sustain/support flag: N.

Official code: NFD. Product type: Selector, Color, Spectacle, Lens, Tint. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1160. Implant flag: N. Life-sustain/support flag: N.

Official code: NFE. Product type: Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation. Official classification: Class II. Official category: Dental. Regulation number: 872.3680. Implant flag: N. Life-sustain/support flag: N.

Official code: NFF. Product type: Device, Storage, Images, Ophthalmic. Official classification: Class I. Official category: Radiology. Regulation number: 892.2010. Implant flag: N. Life-sustain/support flag: N.

Official code: NFG. Product type: Device, Communications, Images, Ophthalmic. Official classification: Class I. Official category: Radiology. Regulation number: 892.2020. Implant flag: N. Life-sustain/support flag: N.

Official code: NFH. Product type: Digitizer, Images, Ophthalmic. Official classification: Class II. Official category: Radiology. Regulation number: 892.2030. Implant flag: N. Life-sustain/support flag: N.

Official code: NFI. Product type: Device, Hardcopy, Images, Ophthalmic. Official classification: Class II. Official category: Radiology. Regulation number: 892.2040. Implant flag: N. Life-sustain/support flag: N.

Official code: NFJ. Product type: System, Image Management, Ophthalmic. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: NFK. Product type: Kit, Repair, Catheter, Hemodialysis. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Hemodialysis Tray Implant flag: N. Life-sustain/support flag: Y.

Official code: NFM. Product type: Expander, Tissue, Orbital. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3320. Implant flag: Y. Life-sustain/support flag: N.

Official code: NFO. Product type: Stimulator, Transcutaneous Electrical, Aesthetic Purposes. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Implant flag: N. Life-sustain/support flag: N.

Official code: NFP. Product type: Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders. Official classification: Class II. Official category: Dental. Regulation number: 872.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: NFQ. Product type: Device, Dental Sonography, For Monitoring Jaw Sounds. Official classification: Class I. Official category: Dental. Regulation number: 872.2050. Implant flag: N. Life-sustain/support flag: N.

Official code: NFR. Product type: Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders. Official classification: Class II. Official category: Dental. Regulation number: 872.2060. Implant flag: N. Life-sustain/support flag: N.

Official code: NFS. Product type: Device, Jaw Tracking, For Monitoring Jaw Positions. Official classification: Class I. Official category: Dental. Regulation number: 872.2060. Implant flag: N. Life-sustain/support flag: N.

Official code: NFT. Product type: Test, Amphetamine, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. Implant flag: N. Life-sustain/support flag: N.

Official code: NFV. Product type: Test, Benzodiazepine, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3170. Implant flag: N. Life-sustain/support flag: N.

Official code: NFW. Product type: Test, Cannabinoid, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3870. Implant flag: N. Life-sustain/support flag: N.

Official code: NFX. Product type: Test, Cholesterol, Total, Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1175. Implant flag: N. Life-sustain/support flag: N.

Official code: NFY. Product type: Test, Cocaine And Cocaine Metabolites, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: NFZ. Product type: Test, Creatinine, Over The Counter. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1225. Implant flag: N. Life-sustain/support flag: N.

Official code: NGA. Product type: Test, Follicle Stimulating Hormone (Fsh), Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: NGB. Product type: Test, Glycosylated Hemoglobin, Over The Counter. Official classification: Class II. Official category: Hematology. Regulation number: 864.7470. Implant flag: N. Life-sustain/support flag: N.

Official code: NGD. Product type: Test, Lactic Acid, Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1450. Implant flag: N. Life-sustain/support flag: N.

Official code: NGE. Product type: Test, Luteinizing Hormone (Lh), Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1485. Implant flag: N. Life-sustain/support flag: N.

Official code: NGG. Product type: Test, Methamphetamine, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3610. Implant flag: N. Life-sustain/support flag: N.

Official code: NGI. Product type: Test, Morphine, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. Implant flag: N. Life-sustain/support flag: N.

Official code: NGJ. Product type: Test, Nitrite, Urinary, Non-Quantitative, Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1510. Implant flag: N. Life-sustain/support flag: N.

Official code: NGK. Product type: Test, Occult Blood, Over The Counter. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. Implant flag: N. Life-sustain/support flag: N.

Official code: NGL. Product type: Test, Opiates, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. Implant flag: N. Life-sustain/support flag: N.

Official code: NGM. Product type: Test, Phencyclidine (Pcp), Over The Counter. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine. Implant flag: N. Life-sustain/support flag: N.

Official code: NGO. Product type: Test, Triglycerides, Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1705. Implant flag: N. Life-sustain/support flag: N.

Official code: NGR. Product type: Tester, Stiffness, Cartilage, Arthroscopic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1100. Implant flag: N. Life-sustain/support flag: N.

Official code: NGS. Product type: Assay, Endotoxin Activity, Chemiluminescent. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3210. Implant flag: N. Life-sustain/support flag: N.

Official code: NGT. Product type: Saline, Vascular Access Flush. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use. Implant flag: N. Life-sustain/support flag: N.

Official code: NGU. Product type: Balloon, Liver Tamponade. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Implant flag: N. Life-sustain/support flag: N.

Official code: NGV. Product type: System, Appendage Closure, Left Atrial. Official classification: Class III. Official category: Unknown. Implant flag: Y. Life-sustain/support flag: N.

Official code: NGX. Product type: Stimulator, Muscle, Powered, For Muscle Conditioning. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5850. A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: NGY. Product type: Cannula, Trocar, Ophthalmic. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: NGZ. Product type: Susceptibility Test Plate, Antifungal. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format. Implant flag: N. Life-sustain/support flag: N.

Official code: NHA. Product type: Abutment, Implant, Dental, Endosseous. Official classification: Class II. Official category: Dental. Regulation number: 872.3630. To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. Implant flag: Y. Life-sustain/support flag: N.

Official code: NHB. Product type: Polymer, Ear, Nose And Throat, Synthetic, Absorbable. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3620. Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials. Implant flag: N. Life-sustain/support flag: N.

Official code: NHC. Product type: Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents). Official classification: Class II. Official category: Neurology. Regulation number: 882.4100. Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain. Implant flag: Y. Life-sustain/support flag: N.

Official code: NHF. Product type: Monitor, Orthotic/Prosthetic. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3025. A monitor, orthotic/prosthetic is a non-invasive, battery-powered, data storage accessory device that is attached to or embedded in medical appliances such as splints, braces, orthotics, prosthetics, and wearable exercise devices, to record how often the appliance is worn, through the use of sensors that record changes in temperature, motion, skin proximity, etc. Implant flag: N. Life-sustain/support flag: N.

Official code: NHG. Product type: Enzyme Immunoassay, Cortisol, Salivary. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1205. The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples. Implant flag: N. Life-sustain/support flag: N.

Official code: NHH. Product type: Device, Discharge, Electrostatic (For Pain Relief). Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain Implant flag: N. Life-sustain/support flag: N.

Official code: NHI. Product type: Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation, Implant flag: N. Life-sustain/support flag: N.

Official code: NHJ. Product type: Device, Positive Pressure Breathing, Intermittent. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5905. Implant flag: N. Life-sustain/support flag: N.

Official code: NHK. Product type: Resuscitator, Manual, Non Self-Inflating. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5905. A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag. Implant flag: N. Life-sustain/support flag: Y.

Official code: NHL. Product type: Stimulator, Electrical, Implanted, For Parkinsonian Symptoms. Official classification: Class III. Official category: Unknown. Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication. Implant flag: Y. Life-sustain/support flag: N.

Official code: NHM. Product type: Sheet, Recording, Breast Examination. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2990. This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination. Implant flag: N. Life-sustain/support flag: N.

Official code: NHN. Product type: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use. Implant flag: N. Life-sustain/support flag: N.

Official code: NHO. Product type: Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1500. A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture. Implant flag: N. Life-sustain/support flag: N.

Official code: NHP. Product type: Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1500. A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture Implant flag: N. Life-sustain/support flag: N.

Official code: NHQ. Product type: Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1500. A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture Implant flag: N. Life-sustain/support flag: N.

Official code: NHS. Product type: Assay, Genotype, Hiv Drug Resistance, In Vitro. Official classification: Class II. Official category: Immunology. Regulation number: 866.3950. Hiv-1 drug resistance genotyping Implant flag: N. Life-sustain/support flag: N.

Official code: NHT. Product type: Assay, Nucleic Acid Amplification, Bacillus Anthracis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3045. An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth. Implant flag: N. Life-sustain/support flag: N.

Official code: NHV. Product type: System, Water Purification, General Medical Use. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5665. The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing. Implant flag: N. Life-sustain/support flag: N.

Official code: NHW. Product type: Electrode, Pacing And Cardioversion, Temporary, Epicardial. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3680. The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days. Implant flag: N. Life-sustain/support flag: Y.

Official code: NHX. Product type: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp). Official classification: Class II. Official category: Immunology. Regulation number: 866.5775. The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis. Implant flag: N. Life-sustain/support flag: N.

Official code: NHY. Product type: Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3480. These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera. Implant flag: N. Life-sustain/support flag: N.

Official code: NHZ. Product type: Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3400. These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera. Implant flag: N. Life-sustain/support flag: N.

Official code: NIA. Product type: Assay, Direct, Nucleic Acid Amplification, Influenza Virus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3330. These reagents are nucleic acid primers and probes for the amplification and identification of Influenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera. Implant flag: N. Life-sustain/support flag: N.

Official code: NIC. Product type: Lens, Contact, For Reading Discomfort. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5925. This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. Implant flag: N. Life-sustain/support flag: N.

Official code: NID. Product type: Assay, Proliferation, In Vitro, T Lymphocyte. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: NIE. Product type: Catheter, Hemodialysis, Triple Lumen, Non-Implanted. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion. Implant flag: N. Life-sustain/support flag: Y.

Official code: NIF. Product type: Catheter, Hemodialysis, Triple Lumen, Implanted. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIG. Product type: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods. Implant flag: N. Life-sustain/support flag: N.

Official code: NIH. Product type: Disinfectant, Subsystem, Water Purification. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5665. Disinfectant intended for reprocessing water purification systems for hemodialysis. Implant flag: N. Life-sustain/support flag: N.

Official code: NII. Product type: Disinfectant, Dialysate Delivery System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5860. Disinfectant intended for reprocessing dialysate delivery systems. Implant flag: N. Life-sustain/support flag: N.

Official code: NIJ. Product type: System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology Implant flag: N. Life-sustain/support flag: N.

Official code: NIK. Product type: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D). Official classification: Class III. Official category: Unknown. These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIM. Product type: Stent, Carotid. Official classification: Class III. Official category: Unknown. Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIN. Product type: Stent, Renal. Official classification: Class III. Official category: Unknown. Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIO. Product type: Stent, Iliac. Official classification: Class III. Official category: Unknown. Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIP. Product type: Stent, Superficial Femoral Artery. Official classification: Class III. Official category: Unknown. Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIQ. Product type: Coronary Drug-Eluting Stent. Official classification: Class III. Official category: Unknown. Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIU. Product type: Stent, Superficial Femoral Artery, Drug-Eluting. Official classification: Class III. Official category: Unknown. Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIV. Product type: Coronary Covered Stent. Official classification: HDE. Official category: Unknown. Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NIX. Product type: Hearing Aid, Air Conduction, Transcutaneous System. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3950. The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing. It consists of an air conduction hearing aid attached to a surgically fitted tube system. The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear). The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal. Implant flag: Y. Life-sustain/support flag: N.

Official code: NIY. Product type: Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis Implant flag: N. Life-sustain/support flag: N.

Official code: NIZ. Product type: Lens, Iris Reconstruction. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJA. Product type: Accessory, System, External Fixator, Containing Antimicrobial Agent. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJB. Product type: Orthosis, Truncal, For Dysmenorrhea. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache. Implant flag: N. Life-sustain/support flag: N.

Official code: NJC. Product type: Clip, Vas Deferens. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJD. Product type: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3535. Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJE. Product type: Intracranial Neurovascular Stent. Official classification: HDE. Official category: Unknown. An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJF. Product type: Antibodies, Anti-Actin, Anti-Smooth Muscle. Official classification: Class II. Official category: Immunology. Regulation number: 866.5120. The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis. Implant flag: N. Life-sustain/support flag: N.

Official code: NJG. Product type: Flasher, Afterimage, Ophthalmic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1300. Implant flag: N. Life-sustain/support flag: N.

Official code: NJH. Product type: Lens, Spectacle (Prescription), For Reading Discomfort. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5844. Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. Implant flag: N. Life-sustain/support flag: N.

Official code: NJJ. Product type: Tonometer, Analyzer, Ocular Blood Flow. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1930. Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume. Implant flag: N. Life-sustain/support flag: N.

Official code: NJK. Product type: Valve, Pulmonary. Official classification: Class III. Official category: Unknown. To improve lung function in patients with emphysema Implant flag: Y. Life-sustain/support flag: N.

Official code: NJL. Product type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing. Official classification: Class III. Official category: Unknown. This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJM. Product type: Bracket, Ceramic, Orthodontic. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position. Implant flag: N. Life-sustain/support flag: N.

Official code: NJO. Product type: System, Mycolic Acid Analysis, Mycobacterium Tuberculosis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3370. A mycolic acids analysis system is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed and pattern recognition software. The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with extraction and analysis of mycolic acids. Results should be interpreted in conjunction with other laboratory observations and procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: NJR. Product type: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status. Implant flag: N. Life-sustain/support flag: N.

Official code: NJT. Product type: Immunohistochemistry Reagents And Kits. Official classification: Class I. Official category: Hematology. Regulation number: 864.1860. according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Implant flag: N. Life-sustain/support flag: N.

Official code: NJU. Product type: Suture, Nonabsorbable, Nitinol. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4495. Soft tissue approximation. Implant flag: Y. Life-sustain/support flag: N.

Official code: NJV. Product type: Test, Albumin Cobalt Binding. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1215. The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin. Implant flag: N. Life-sustain/support flag: N.

Official code: NJW. Product type: Control Material, Her-2/Neu, Immunohistochemistry. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays. Implant flag: N. Life-sustain/support flag: N.

Official code: NJZ. Product type: Extractor, Vein. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting. It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein. Implant flag: N. Life-sustain/support flag: N.

Official code: NKA. Product type: System, Documentation, Breast Lesion. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2990. A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam. Implant flag: N. Life-sustain/support flag: N.

Official code: NKB. Product type: Thoracolumbosacral Pedicle Screw System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: NKC. Product type: Tubing/Tubing With Filter, Insufflation, Laparoscopic. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: NKE. Product type: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P). Official classification: Class III. Official category: Unknown. These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NKF. Product type: Immunohistochemistry Antibody Assay, C-Kit. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. Identification/Intended Use - The anti-c-KIT primary antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or manual assay. It is indicated as an aid in the selection of GIST patients who may qualify for imatinib mesylate therapy within the context of the patient's clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. The test is not intended as the sole basis for making the diagnosis of GIST and is not intended as the sole basis for selecting imatinib mesylate therapy. A negative result would not necessarily exclude the diagnosis of GIST Implant flag: N. Life-sustain/support flag: N.

Official code: NKG. Product type: Posterior Cervical Screw System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3075. Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: NKI. Product type: Goniometer With Electrodes. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1500. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data. Implant flag: N. Life-sustain/support flag: N.

Official code: NKJ. Product type: Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter. Official classification: Class I. Official category: Dental. Regulation number: 872.3540. OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use. Implant flag: N. Life-sustain/support flag: N.

Official code: NKK. Product type: Needle, Hypodermic, Single Lumen, Reprocessed. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKM. Product type: Mitral Valve Repair Devices. Official classification: Class III. Official category: Unknown. To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus. Implant flag: Y. Life-sustain/support flag: N.

Official code: NKN. Product type: Syringe, Piston, Reprocessed. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKO. Product type: System, Balloon, Intra-Aortic And Control, Reprocessed. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3535. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKP. Product type: Injector, Contrast Medium, Automatic, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: NKQ. Product type: Guidewire, Catheter, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1330. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKR. Product type: System, Catheter Control, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1290. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKS. Product type: Catheter, Steerable, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1280. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKT. Product type: Injector And Syringe, Angiographic, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKU. Product type: Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. Implant flag: N. Life-sustain/support flag: N.

Official code: NKW. Product type: Actuator, Syringe, For Injector, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1670. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKX. Product type: Needle, Phacoemulsification, Reprocessed. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4670. Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKY. Product type: Blade, Keratome, Reprocessed. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4370. Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NKZ. Product type: Endoilluminator, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Used intraocularly to provide light into the posterior of the eye during retinal surgery. Same as product code MPA, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLA. Product type: Knife, Ophthalmic, Reprocessed. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLB. Product type: Trocar, Tracheal, Laryngeal, Sinus, Reprocessed. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Same as KBG, KAB, and KCI but need one code for reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLC. Product type: Bracket, Plastic, Orthodontic, Reprocessed. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. same as DYW except it is being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLD. Product type: Instrument, Diamond, Dental, Reprocessed. Official classification: Class I. Official category: Dental. Regulation number: 872.4535. same as DZP except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLE. Product type: Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. Same as BWH except it is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLF. Product type: Oximeter, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLG. Product type: Catheter, Intracardiac Mapping, High-Density, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1220. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLH. Product type: Catheter, Recording, Electrode, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1220. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLI. Product type: Catheter, Angiography, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLJ. Product type: Stripper, Vein, External, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4885. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLK. Product type: Needle, Biopsy, Cardiovascular, Reprocessed. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLL. Product type: Staple, Implantable, Reprocessed. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4750. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLM. Product type: Laparoscope, General & Plastic Surgery, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLN. Product type: Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed. Official classification: Class II. Official category: Neurology. Regulation number: 882.4310. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLO. Product type: Drills, Burrs, Trephines And Accessories (Manual), Reprocessed. Official classification: Class II. Official category: Neurology. Regulation number: 882.4300. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLP. Product type: Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed. Official classification: Class II. Official category: Neurology. Regulation number: 882.4305. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLQ. Product type: Single-Use Reprocessed Ultrasonic Surgical Instruments. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLR. Product type: Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLS. Product type: Instrument, Biopsy, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Intended to obtain samples of tissue by cutting and/or other mechanical means. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLT. Product type: Snare, Flexible, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLU. Product type: Forceps, Biopsy, Electric, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLV. Product type: Electrode, Flexible Suction Coagulator, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. The "electorde, flexible suction coagulator, reprocessed" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLW. Product type: Electrode, Electrosurgical, Active, Urological, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf) Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf) Implant flag: N. Life-sustain/support flag: N.

Official code: NLX. Product type: Needle, Pneumoperitoneum, Spring Loaded, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. The "needle, penum...." is intended to insufflate the peritoneal cavity with gas during endoscopic procedures. This device is indiated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NLY. Product type: Microdebrider, Ent, High Speed, Single Use, Reprocessed. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4140. ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.) Implant flag: N. Life-sustain/support flag: N.

Official code: NLZ. Product type: Bur, Ent, Diamond Coated, Single Use, Reprocessed. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4140. ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMA. Product type: Tube, Tracheal, Reprocessed. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5730. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: Y.

Official code: NMB. Product type: Catheter, Oximeter, Fiber Optic, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1230. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMC. Product type: Mask, Ventilator, Non-Continuous, Reprocessed. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5905. Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure). Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMD. Product type: Oximeter, Tissue Saturation, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NME. Product type: Bur, Diamond Coated, Reprocessed. Official classification: Class I. Official category: Dental. Regulation number: 872.3240. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMF. Product type: Clamp, Vascular, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4450. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMG. Product type: Forceps, Biopsy, Gynecological, Reprocessed. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMH. Product type: Laparoscope And Accessories, Gynecologic, Reprocessed. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMI. Product type: Laparoscopic Insufflator And Accessories, Reprocessed. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1730. Implant flag: N. Life-sustain/support flag: N.

Official code: NMJ. Product type: Clip, Implantable, Reprocessed. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: Y. Life-sustain/support flag: N.

Official code: NMK. Product type: Trocar, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1390. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NML. Product type: Catheter, Biliary, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5010. same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMM. Product type: Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf) Implant flag: N. Life-sustain/support flag: N.

Official code: NMN. Product type: Instrument, Clip, Forming/Cutting, Reprocessed. Official classification: Class I. Official category: Neurology. Regulation number: 882.4190. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMP. Product type: Needle, Isotope, Reprocessed. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMR. Product type: Needle, Spinal, Short Term, Reprocessed. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5150. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMT. Product type: Needle, Catheter, Reprocessed. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMU. Product type: Needle, Gastro-Urology, Reprocessed. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMW. Product type: Needle, Dental, Reprocessed. Official classification: Class I. Official category: Dental. Regulation number: 872.4730. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMX. Product type: Needle And Needle Set, Gastro-Urology, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NMY. Product type: Needle, Endoscopic, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNA. Product type: Biopsy Device, Percutaneous, Reprocessed. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNB. Product type: Needle, Reproduction, Assisted, Reprocessed. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6100. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNC. Product type: Needle, Aspiration And Needle, Reprocessed. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNE. Product type: Needle, Fistula, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNG. Product type: Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNH. Product type: Needle, Conduction, Anesthesia, Reprocessed. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5150. A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NNI. Product type: Container, Specimen, Non-Sterile. Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: NNJ. Product type: Gustometer, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.1500. Implant flag: N. Life-sustain/support flag: N.

Official code: NNK. Product type: Container, Specimen Mailer And Storage, Non-Sterile. Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: NNL. Product type: Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile. Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. Implant flag: N. Life-sustain/support flag: N.

Official code: NNN. Product type: Crimper, Wire, Ent, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JXT. Implant flag: N. Life-sustain/support flag: N.

Official code: NNO. Product type: Jig, Piston Cutting, Ent, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JXY. Implant flag: N. Life-sustain/support flag: N.

Official code: NNP. Product type: Die, Wire Bending, Ent, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JXW. Implant flag: N. Life-sustain/support flag: N.

Official code: NNQ. Product type: Forceps, Wire Closure, Ent, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JXX. Implant flag: N. Life-sustain/support flag: N.

Official code: NNR. Product type: Block, Cutting, Ent, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JXS. Implant flag: N. Life-sustain/support flag: N.

Official code: NNS. Product type: Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code LRE. Implant flag: N. Life-sustain/support flag: N.

Official code: NNT. Product type: Punch, Gelfoam, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ Implant flag: N. Life-sustain/support flag: N.

Official code: NNU. Product type: Scissors, Wire Cutting, Ent, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JYA. Implant flag: N. Life-sustain/support flag: N.

Official code: NNV. Product type: Vise, Ossicular Finger, Non-Sterile. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3540. Prosthesis modification instrument for ossicular replacement surgery; see product code JYB. Implant flag: N. Life-sustain/support flag: N.

Official code: NNW. Product type: Bag, Urine Collection, Leg, For External Use, Non-Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Urine collector and accessories; see product code FAQ. Implant flag: N. Life-sustain/support flag: N.

Official code: NNX. Product type: Device, Incontinence, Urosheath Type, Non-Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Urine collector and accessories; see product code EXJ Implant flag: N. Life-sustain/support flag: N.

Official code: NNY. Product type: Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Urine collector and accessories; see product code EYT. Implant flag: N. Life-sustain/support flag: N.

Official code: NNZ. Product type: System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Urine collector and accessories; see product code EYZ. Implant flag: N. Life-sustain/support flag: N.

Official code: NOA. Product type: Device, Paste-On For Incontinence, Non-Sterile. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. Urine collector and accessories; see product code EXI. Implant flag: N. Life-sustain/support flag: N.

Official code: NOB. Product type: Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. manual toothbrush; see product code MCF Implant flag: N. Life-sustain/support flag: N.

Official code: NOC. Product type: Splint, Extremity, Non-Inflatable, External, Non-Sterile. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3910. Non-inflatable extremity splint; See product code fyh. Implant flag: N. Life-sustain/support flag: N.

Official code: NOD. Product type: Board, Arm (With Cover), Non-Sterile. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3910. Implant flag: N. Life-sustain/support flag: N.

Official code: NOE. Product type: Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2. Official classification: Class II. Official category: Immunology. Regulation number: 866.5600. The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein. Implant flag: N. Life-sustain/support flag: N.

Official code: NOF. Product type: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations. Official classification: Class II. Official category: Dental. Regulation number: 872.3661. An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software. Implant flag: N. Life-sustain/support flag: N.

Official code: NOG. Product type: Topographer, Corneal, Battery Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1350. Topographer, corneal, battery powered Implant flag: N. Life-sustain/support flag: N.

Official code: NOH. Product type: Photokeratoscope, Battery Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1350. external aesthetic restoration prosthesis Implant flag: N. Life-sustain/support flag: N.

Official code: NOI. Product type: Stand, Instrument, Ophthalmic, Battery Powered. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1860. AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position. Implant flag: N. Life-sustain/support flag: N.

Official code: NOJ. Product type: Prosthesis, Breast, External, No Adhesive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3800. external aesthetic restoration prosthesis Implant flag: N. Life-sustain/support flag: N.

Official code: NOK. Product type: Material, External Aesthetic Restoration, No Adhesive. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.3800. external aesthetic restoration prosthesis Implant flag: N. Life-sustain/support flag: N.

Official code: NOM. Product type: Antigen, Galactomannan, Aspergillus Spp.. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3040. The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis. Implant flag: N. Life-sustain/support flag: N.

Official code: NON. Product type: Forceps, Biopsy, Non-Electric, Reprocessed. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1075. same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NOO. Product type: Clamp, Dialysis Arm. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5540. The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation. Implant flag: N. Life-sustain/support flag: N.

Official code: NOP. Product type: Elisa, Antibody, West Nile Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3940. The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients. Implant flag: N. Life-sustain/support flag: N.

Official code: NOT. Product type: Microscope, Automated, Image Analysis, Operator Intervention. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention. Implant flag: N. Life-sustain/support flag: N.

Official code: NOU. Product type: Continuous, Ventilator, Home Use. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device. Implant flag: N. Life-sustain/support flag: Y.

Official code: NOV. Product type: Anchor, Suture, Bone Fixation, Metallic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim. Implant flag: Y. Life-sustain/support flag: N.

Official code: NOX. Product type: Filler, Bone Void, Synthetic Peptide. Official classification: Class III. Official category: Unknown. The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NOY. Product type: Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5550. The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH). Implant flag: Y. Life-sustain/support flag: N.

Official code: NOZ. Product type: Assay, 1,5-Anhydroglucitol (15ag). Official classification: Class II. Official category: Hematology. Regulation number: 864.7470. The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes. Implant flag: N. Life-sustain/support flag: N.

Official code: NPB. Product type: System, Monitoring, For Progress Of Labor. Official classification: Class II. Official category: Ophthalmic. Regulation number: 884.2800. This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor. Implant flag: N. Life-sustain/support flag: N.

Official code: NPE. Product type: Material, Embolization, Neurovascular, Polymerizing Or Precipitating. Official classification: Class III. Official category: Unknown. This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations. Implant flag: N. Life-sustain/support flag: Y.

Official code: NPF. Product type: Monitor, Apnea, Home Use. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2377. Same as the identification for product code FLS, just add home use Implant flag: N. Life-sustain/support flag: Y.

Official code: NPG. Product type: Catheter, Infusion, Syringe. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1210. To provide physician specified fluids both perivascular or intraluminal to the perivascular space. Implant flag: N. Life-sustain/support flag: N.

Official code: NPH. Product type: Antigen, Cartilage Oligomeric Matrix Protein (Comp). Official classification: Class II. Official category: Immunology. Regulation number: 866.5775. COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings, aids in identifying aggressive destruction of joint tissue in Rheumatoid Arthritis. Implant flag: N. Life-sustain/support flag: N.

Official code: NPJ. Product type: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3560. The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement. Implant flag: Y. Life-sustain/support flag: N.

Official code: NPK. Product type: Barrier, Synthetic, Intraoral. Official classification: Class II. Official category: Dental. Regulation number: 872.3930. A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials. Implant flag: Y. Life-sustain/support flag: N.

Official code: NPL. Product type: Barrier, Animal Source, Intraoral. Official classification: Class II. Official category: Dental. Regulation number: 872.3930. An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants. Implant flag: Y. Life-sustain/support flag: N.

Official code: NPM. Product type: Bone Grafting Material, Animal Source. Official classification: Class II. Official category: Dental. Regulation number: 872.3930. A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw. Implant flag: Y. Life-sustain/support flag: N.

Official code: NPO. Product type: Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3045. A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth Implant flag: N. Life-sustain/support flag: N.

Official code: NPP. Product type: Reprocessed Blood Pressure Cuff. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1120. The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement. Implant flag: N. Life-sustain/support flag: N.

Official code: NPQ. Product type: Test, Factor V Leiden Mutations, Genomic Dna Pcr. Official classification: Class II. Official category: Hematology. Regulation number: 864.7280. In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. Implant flag: N. Life-sustain/support flag: N.

Official code: NPR. Product type: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr. Official classification: Class II. Official category: Hematology. Regulation number: 864.7280. In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. Implant flag: N. Life-sustain/support flag: N.

Official code: NPS. Product type: Tricuspid Valve Repair Device, Percutaneously Delivered. Official classification: Class III. Official category: Unknown. These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NPT. Product type: Aortic Valve, Prosthesis, Percutaneously Delivered. Official classification: Class III. Official category: Unknown. To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NPU. Product type: Prosthesis, Mitral Valve, Percutaneously Delivered. Official classification: Class III. Official category: Unknown. These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NPV. Product type: Pulmonary Valve Prosthesis Percutaneously Delivered. Official classification: HDE. Official category: Unknown. These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NPW. Product type: Percutaneously Delivered Prostheses And Tricuspid Valves. Official classification: Class III. Official category: Unknown. These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NPZ. Product type: Bone Grafting Material, Dental, With Biologic Component. Official classification: Class III. Official category: Dental. Regulation number: 872.3930. Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQA. Product type: Biologic Material, Dental. Official classification: Class III. Official category: Dental. Regulation number: 872.3930. Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQB. Product type: Conformer, Ophthalmic, Biological Tissue. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3130. The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQC. Product type: Test, Breath Analysis, Volatile Organic Compounds. Official classification: HDE. Official category: Unknown. Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients Implant flag: N. Life-sustain/support flag: N.

Official code: NQD. Product type: Cardiac C-Reactive Protein, Antigen, Antiserum, And Control. Official classification: Class II. Official category: Immunology. Regulation number: 866.5270. In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments. Implant flag: N. Life-sustain/support flag: N.

Official code: NQE. Product type: Microscope, Specular. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1850. Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro. Implant flag: N. Life-sustain/support flag: N.

Official code: NQF. Product type: Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. The epidermal growth factor receptor (EGFR) antibody/assay is a qualitative immunohistochemical antibody/assay to identify EGFR expression in normal and neoplastic tissues routinely-fixed for histological evaluation. EGFR antibody/assay specifically detects the EGFR (HER1) protein in EGFR-expressing cells. This antibody/assay is indicated as an aid in identifying colorectal cancer patients eligible for treatment with cetuximab, a monoclonal antibody drug. This will be a specialized subcategory for EGFR immunohistochemistry assays under the general heading of the regulation for all Immunohistochemistry assays. Implant flag: N. Life-sustain/support flag: N.

Official code: NQG. Product type: Stabilizer, Heart, Non-Compression, Reprocessed. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.4500. The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NQH. Product type: Sensor, Pressure, Aneurysm, Implantable. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2855. This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQI. Product type: System, Immunomagnetic, Circulating Cancer Cell, Enumeration. Official classification: Class II. Official category: Immunology. Regulation number: 866.6020. In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival. Implant flag: N. Life-sustain/support flag: N.

Official code: NQJ. Product type: Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload. Implant flag: N. Life-sustain/support flag: Y.

Official code: NQK. Product type: Maggots, Medical. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Phaenicia sericacta (blow fly) larvae are harvested and provided disinfected for use in debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds. See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702) Implant flag: N. Life-sustain/support flag: N.

Official code: NQL. Product type: System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1055. Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders. Implant flag: N. Life-sustain/support flag: N.

Official code: NQM. Product type: Immunoassay For Detection Of Amniotic Fluid Protein(S).. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1550. The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture. Implant flag: N. Life-sustain/support flag: N.

Official code: NQN. Product type: Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention. Implant flag: N. Life-sustain/support flag: N.

Official code: NQO. Product type: Prosthesis, Spinous Process Spacer/Plate. Official classification: Class III. Official category: Unknown. This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQP. Product type: Posterior Metal/Polymer Spinal System, Fusion. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQQ. Product type: System, Imaging, Optical Coherence Tomography (Oct). Official classification: Class II. Official category: Radiology. Regulation number: 892.1560. This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging. Implant flag: N. Life-sustain/support flag: N.

Official code: NQR. Product type: Sealant, Dural. Official classification: Class III. Official category: Unknown. Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NQS. Product type: Bracket, Metal, Orthodontic, Reprocessed. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. Intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NQT. Product type: Dislodger, Stone, Flexible, Ureteral, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4680. A ureteral stone dislodger is a device that consists of a bougie or a catheter with a special flexible tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NQU. Product type: Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4680. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NQV. Product type: Catheter, Suction, Tracheobronchial, Reprocessed. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4680. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NQW. Product type: Orthosis, Spine, Plate, Laminoplasty, Metal. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3050. This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure. Implant flag: Y. Life-sustain/support flag: N.

Official code: NQX. Product type: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings. Implant flag: N. Life-sustain/support flag: N.

Official code: NQY. Product type: Ventilator, Continuous, Minimal Ventilatory Support, Home Use. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home. Implant flag: N. Life-sustain/support flag: Y.

Official code: NQZ. Product type: Antigen, Invasive Fungal Pathogens. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3050. Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination. Implant flag: N. Life-sustain/support flag: N.

Official code: NRA. Product type: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing. Official classification: Class III. Official category: Unknown. This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis. Implant flag: Y. Life-sustain/support flag: N.

Official code: NRB. Product type: Wound Cleaner, Ultrasound. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4410. The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound Implant flag: N. Life-sustain/support flag: N.

Official code: NRC. Product type: Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5425. Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, not intended as intralabial pads or reusable menstrual pads. These are made of common cellulosic or synthetic material with an established safety profile. Implant flag: N. Life-sustain/support flag: N.

Official code: NRD. Product type: Unit, Operative Dental, Accessories. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit. Implant flag: N. Life-sustain/support flag: N.

Official code: NRF. Product type: Material, Quality Control, Semen Analysis. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells. Implant flag: N. Life-sustain/support flag: N.

Official code: NRH. Product type: System, Breath Measurement. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1820. Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: NRI. Product type: Autoantibodies, Nuclear Pore Glycoprotein Gp210. Official classification: Class II. Official category: Immunology. Regulation number: 866.5090. The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis. Implant flag: N. Life-sustain/support flag: N.

Official code: NRJ. Product type: Ultrasound, Skin Permeation. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4410. Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc. Implant flag: N. Life-sustain/support flag: N.

Official code: NRK. Product type: Kit, Test, Olfactory. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1600. The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card. The device is intended for screening neurological disorder. Implant flag: N. Life-sustain/support flag: N.

Official code: NRL. Product type: Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3045. The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax. Implant flag: N. Life-sustain/support flag: N.

Official code: NRN. Product type: Leeches, Medicinal. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. The animal is a bloodsucking aquatic animal living in fresh water. The device should be indicated as: "an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding." See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702) Implant flag: N. Life-sustain/support flag: N.

Official code: NRP. Product type: Sirolimus Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3840. Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus. Implant flag: N. Life-sustain/support flag: N.

Official code: NRQ. Product type: Blade-Form Endosseous Dental Implant. Official classification: Class II. Official category: Dental. Regulation number: 872.3640. Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. Implant flag: Y. Life-sustain/support flag: N.

Official code: NRS. Product type: Control Material, Blood Circulating Epithelial Cancer Cell. Official classification: Class II. Official category: Hematology. Regulation number: 864.8625. The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells. Implant flag: N. Life-sustain/support flag: N.

Official code: NRU. Product type: Chair, Dental, Without Operative Unit. Official classification: Class I. Official category: Dental. Regulation number: 872.6250. A dental chair is a device, usually powered, that is intended to seat a patient in the proper position to perform a dental procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: NRV. Product type: Implantable Radio Frequency Transponder System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6300. An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient Implant flag: Y. Life-sustain/support flag: N.

Official code: NRW. Product type: Stimulator, Intramuscular, Automatic. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5580. The Automatic Intramuscular Stimulator is a device that aids muscle stimulation by using a method called dry needling for treatment. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter. The motor unit has a mounted disposal syringe and a needle mounting hardware for a disposable needle, and enables the practitioner to administer treatment with less physical effort. An EMG needle is used instead of an acupuncture needle because it is less flexible than the acupuncture needle Implant flag: N. Life-sustain/support flag: N.

Official code: NRX. Product type: Complement 4d (C4d) And Complement Receptor 1 (Cr1). Official classification: Class II. Official category: Immunology. Regulation number: 866.5820. The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus. Implant flag: N. Life-sustain/support flag: N.

Official code: NRY. Product type: Catheter, Thrombus Retriever. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode. Implant flag: N. Life-sustain/support flag: N.

Official code: NRZ. Product type: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided. Official classification: Class III. Official category: Unknown. An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: NSA. Product type: Over-The-Counter Automated External Defibrillator. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.5310. Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs. Implant flag: N. Life-sustain/support flag: Y.

Official code: NSB. Product type: Patient Personal Hygiene Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. This device contains items given to an individual during their hospital stay. Implant flag: N. Life-sustain/support flag: N.

Official code: NSC. Product type: Injector, Pen. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: NSD. Product type: Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence. Official classification: Class III. Official category: Unknown. In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer. It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: NSF. Product type: Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment. Official classification: Class II. Official category: Immunology. Regulation number: 866.6030. In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld). Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months. Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the existing hcc practice guidelines in oncology. Implant flag: N. Life-sustain/support flag: N.

Official code: NSI. Product type: System, Imaging, Esophageal, Wireless, Capsule. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1300. THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL. Implant flag: N. Life-sustain/support flag: N.

Official code: NSJ. Product type: Restoration, Noble Metal. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals. Implant flag: N. Life-sustain/support flag: N.

Official code: NSK. Product type: Dentures, Partial. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured partial dentures are manufactured as finished products from denture resins and other supporting materials. Implant flag: N. Life-sustain/support flag: N.

Official code: NSL. Product type: Dentures, Full. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured full dentures are manufactured as finished products from denture resins. Implant flag: N. Life-sustain/support flag: N.

Official code: NSM. Product type: Restoration, Resin. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins. Implant flag: N. Life-sustain/support flag: N.

Official code: NSN. Product type: Restoration, Resin, Crown And Bridge. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins. Implant flag: N. Life-sustain/support flag: N.

Official code: NSO. Product type: Restoration, Porcelain-Fused-To-Metal. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys. Implant flag: N. Life-sustain/support flag: N.

Official code: NSP. Product type: Restoration, Porcelain. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains. Implant flag: N. Life-sustain/support flag: N.

Official code: NSQ. Product type: Restoration, Base Metal. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals. Implant flag: N. Life-sustain/support flag: N.

Official code: NSR. Product type: Prosthesis, Orthodontic. Official classification: Not classified. Official category: Unknown. Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis. Implant flag: N. Life-sustain/support flag: N.

Official code: NSS. Product type: Electronic Media, Nausea. Official classification: Not classified. Official category: Unknown. Treatment of nausea and vomiting associated with morning sickness and motion sickness. Implant flag: N. Life-sustain/support flag: N.

Official code: NST. Product type: Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM, INTERFERES WITH THE BINDING OF ACETYLCHOLINE, A NEURAL TRANSMITTER AT THE JUNCTION OF NERVES WITH MUSCLES. AUTOANTIBODY CAN ALSO BIND TO OTHER PORTIONS OF THE ACETYLCHOLINE RECEPTOR WITHOUT INTERFERING WITH ACETYLCHOLINE BINDING. PRESENCE OF AUTOANTIBODY ALONG WITH CLINICAL SIGNS AND SYMPTOMS ARE USUALLY HIGHLY SUGGESTIVE OF MYASTHENIA GRAVIS. ACETYLCHOLINE RECEPTOR AUTOANTIBODY CAN ALSO OCCUR IN THE PRESENCE OF AUTOANTIBODIES TO OTHER BODY SUBSTANCES. Implant flag: N. Life-sustain/support flag: N.

Official code: NSU. Product type: Instrumentation For Clinical Multiplex Test Systems. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de Implant flag: N. Life-sustain/support flag: N.

Official code: NTB. Product type: System, Ablation, Ultrasound And Accessories. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery. Implant flag: N. Life-sustain/support flag: N.

Official code: NTC. Product type: Nursing Pad, Hydrogel. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5630. Implant flag: N. Life-sustain/support flag: N.

Official code: NTE. Product type: Temporary Carotid Catheter For Embolic Capture. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i Implant flag: N. Life-sustain/support flag: N.

Official code: NTG. Product type: Prosthesis, Ankle, Uncemented, Non-Constrained. Official classification: Class III. Official category: Unknown. An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NTH. Product type: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays. Official classification: Class II. Official category: Immunology. Regulation number: 866.4700. Implant flag: N. Life-sustain/support flag: N.

Official code: NTI. Product type: Drug Metabolizing Enzyme Genotyping Systems. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3360. Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system. Implant flag: N. Life-sustain/support flag: N.

Official code: NTK. Product type: Light Transmission Caries Detector. Official classification: Class II. Official category: Dental. Regulation number: 872.1745. Implant flag: N. Life-sustain/support flag: N.

Official code: NTM. Product type: Antigen, Inflammatory Response Marker, Sepsis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3210. An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: NTN. Product type: Led Light Source. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals Implant flag: N. Life-sustain/support flag: N.

Official code: NTO. Product type: Rinse, Oral, Antibacterial (By Physical Means). Official classification: Class II. Official category: Dental. Regulation number: 872.5580. Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion. Implant flag: N. Life-sustain/support flag: N.

Official code: NTR. Product type: Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells. Official classification: Class I. Official category: Hematology. Regulation number: 864.1860. MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS. Implant flag: N. Life-sustain/support flag: N.

Official code: NTU. Product type: Evoked Potential Stimulator, Thermal. Official classification: Class II. Official category: Neurology. Regulation number: 882.1870. Intended to evaluate the functionality of human pain reception and transmission of sensory pathways Implant flag: N. Life-sustain/support flag: N.

Official code: NTV. Product type: Myeloperoxidase, Immunoassay, System, Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.5600. MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH. Implant flag: N. Life-sustain/support flag: N.

Official code: NTW. Product type: System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.4070. System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing Implant flag: N. Life-sustain/support flag: N.

Official code: NTX. Product type: Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68). Official classification: Class I. Official category: General Hospital. Regulation number: 880.5630. A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING. Implant flag: N. Life-sustain/support flag: N.

Official code: NTY. Product type: System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES. Implant flag: N. Life-sustain/support flag: N.

Official code: NTZ. Product type: Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate. Implant flag: N. Life-sustain/support flag: N.

Official code: NUA. Product type: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection. Official classification: Class II. Official category: Immunology. Regulation number: 866.5900. The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening. Implant flag: N. Life-sustain/support flag: N.

Official code: NUB. Product type: Colonic Irrigation System, General Well Being. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.5220. Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being Implant flag: N. Life-sustain/support flag: N.

Official code: NUC. Product type: Lubricant, Personal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. Implant flag: N. Life-sustain/support flag: N.

Official code: NUD. Product type: Vertebroplasty Compound, Calcium Based. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS. Implant flag: Y. Life-sustain/support flag: N.

Official code: NUF. Product type: Catheter, Neurovasculature, Occluding Balloon. Official classification: Class III. Official category: Neurology. Regulation number: 882.5150. Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management Implant flag: N. Life-sustain/support flag: Y.

Official code: NUH. Product type: Stimulator, Nerve, Transcutaneous, Over-The-Counter. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES Implant flag: N. Life-sustain/support flag: N.

Official code: NUI. Product type: Ultrasound, Infusion, System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature. Implant flag: N. Life-sustain/support flag: N.

Official code: NUJ. Product type: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NUK. Product type: For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NUL. Product type: For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System. Official classification: Not classified. Official category: Unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: NUM. Product type: Autoantibodies, Nuclear Body Protein, Sp100. Official classification: Class II. Official category: Immunology. Regulation number: 866.5090. THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS. Implant flag: N. Life-sustain/support flag: N.

Official code: NUN. Product type: Bone Grafting Material, Human Source. Official classification: Class II. Official category: Dental. Regulation number: 872.3930. INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION. Implant flag: Y. Life-sustain/support flag: N.

Official code: NUP. Product type: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5045. THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS. Implant flag: N. Life-sustain/support flag: N.

Official code: NUQ. Product type: Pad, Menstrual, Reusable. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5435. A reusable, unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile. Implant flag: N. Life-sustain/support flag: N.

Official code: NUR. Product type: Pad, Menstrual, Intralabial. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5435. An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile. Implant flag: N. Life-sustain/support flag: N.

Official code: NUU. Product type: Lens, Contact, Orthokeratology, Overnight. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.5916. Temporary reduction of myopia or refractive error. Implant flag: N. Life-sustain/support flag: N.

Official code: NUV. Product type: Massager, Vacuum, Light Induced Heating. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. The device is intended to temporarily alter the appearance of cellulite Implant flag: N. Life-sustain/support flag: N.

Official code: NUW. Product type: Stimulator, Muscle, Powered, Dental. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5850. Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow. Implant flag: N. Life-sustain/support flag: N.

Official code: NUX. Product type: Cleanser, Denture, Prescription. Official classification: Class I. Official category: Dental. Regulation number: 872.3520. Effervescent tablet for the removal of micro-organisms from removable dentures and retainers. Implant flag: N. Life-sustain/support flag: N.

Official code: NVA. Product type: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES. Implant flag: N. Life-sustain/support flag: N.

Official code: NVB. Product type: Intraocular, Pressure Measuring Device. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.4280. Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma. Implant flag: N. Life-sustain/support flag: N.

Official code: NVC. Product type: Bone, Heterograft. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3015. BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN. Implant flag: Y. Life-sustain/support flag: N.

Official code: NVE. Product type: Washer, Cleaner, Automated, Endoscope. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the endoscopes. Implant flag: N. Life-sustain/support flag: N.

Official code: NVG. Product type: Tissue Culture, Accessories, Dental. Official classification: Class I. Official category: Hematology. Regulation number: 864.2240. Intended to temporarilty nourish cells on an avulsed tooth Implant flag: N. Life-sustain/support flag: N.

Official code: NVH. Product type: Suture, Knot, Mechanical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. In approximation and/or ligation of soft tissue Implant flag: Y. Life-sustain/support flag: N.

Official code: NVI. Product type: Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests. Implant flag: N. Life-sustain/support flag: N.

Official code: NVJ. Product type: Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility. Implant flag: N. Life-sustain/support flag: N.

Official code: NVK. Product type: Laser, Dental, Soft Tissue. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. Implant flag: N. Life-sustain/support flag: N.

Official code: NVM. Product type: Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries Implant flag: N. Life-sustain/support flag: N.

Official code: NVN. Product type: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes. Official classification: Class III. Official category: Unknown. Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NVO. Product type: Spacer, Direct Patient Interface. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5630. Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles. Implant flag: N. Life-sustain/support flag: N.

Official code: NVP. Product type: Holding Chambers, Direct Patient Interface. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5630. Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles Implant flag: N. Life-sustain/support flag: N.

Official code: NVQ. Product type: Bacteriophage And Controls, B. Anthracis Lysis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3045. A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage. Implant flag: N. Life-sustain/support flag: N.

Official code: NVR. Product type: Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar. Official classification: Class III. Official category: Unknown. Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: NVT. Product type: Tubing And Tubing/Filter Fits. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1700. Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope. Implant flag: N. Life-sustain/support flag: N.

Official code: NVV. Product type: Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2100. Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images. Implant flag: N. Life-sustain/support flag: N.

Official code: NVY. Product type: Permanent Defibrillator Electrodes. Official classification: Class III. Official category: Unknown. Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NVZ. Product type: Pulse Generator, Permanent, Implantable. Official classification: Class III. Official category: Unknown. Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NWA. Product type: Prosthesis, Tracheal, Preformed/Molded. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3720. The device is intended to provide support to weakened or constricting airway walls. Implant flag: Y. Life-sustain/support flag: N.

Official code: NWB. Product type: Endoscope, Accessories, Narrow Band Spectrum. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract. Implant flag: N. Life-sustain/support flag: N.

Official code: NWE. Product type: Colon Computed Tomography System, Computer Aided Detection. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review. Implant flag: N. Life-sustain/support flag: N.

Official code: NWF. Product type: Drill, Battery Powered, Subungual Hematoma. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed. Indicated to relieve pressure from subungual hematomas (including black toe). Implant flag: N. Life-sustain/support flag: N.

Official code: NWG. Product type: Autoantibodies, Glutamic Acid Decarboxylase (Gad). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes). Implant flag: N. Life-sustain/support flag: N.

Official code: NWI. Product type: Electrosurgical Electrode Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: NWJ. Product type: Suture, Recombinant Technology. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4494. Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation. Implant flag: Y. Life-sustain/support flag: N.

Official code: NWM. Product type: Immunoassay, Anti-Seizure Drug. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. To aid in management of patients treated with anti-seizure drug. Implant flag: N. Life-sustain/support flag: N.

Official code: NWN. Product type: Laparoscopic Bone Anchor Urethropexy Instrument Kit. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NWO. Product type: Kit, Catheter, Urinary (Exludes Hiv Testing). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Urinary Catheterization Kit (Excludes HIV Testing) Implant flag: N. Life-sustain/support flag: N.

Official code: NWP. Product type: Suprapubic Cystostomy Catheter Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5090. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NWS. Product type: Kit, Choledochoscope, Flexible And Rigid. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Flexible and Rigid Choledochoscope Kit Implant flag: N. Life-sustain/support flag: N.

Official code: NWT. Product type: Endoscopic Cholangiogram Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NWU. Product type: Endoscope Introducer Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: NWV. Product type: Laparoscopic Accessories, Gynecologic. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. Implant flag: N. Life-sustain/support flag: N.

Official code: NWW. Product type: Hysteroscope Accessories. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1690. Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts. Implant flag: N. Life-sustain/support flag: N.

Official code: NWX. Product type: Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring. Official classification: Class III. Official category: Unknown. To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion. Implant flag: N. Life-sustain/support flag: N.

Official code: NWY. Product type: Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies. Official classification: Not classified. Official category: Unknown. Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood. Implant flag: N. Life-sustain/support flag: N.

Official code: NWZ. Product type: Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3045. Aid in the identification of Bacillus Anthracis Implant flag: N. Life-sustain/support flag: N.

Official code: NXA. Product type: Tracheotomy Care Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5800. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NXB. Product type: Dispenser, Solid Medication. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication. Implant flag: N. Life-sustain/support flag: N.

Official code: NXC. Product type: Aligner, Sequential. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. Implant flag: N. Life-sustain/support flag: N.

Official code: NXD. Product type: Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3332. Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control. Implant flag: N. Life-sustain/support flag: N.

Official code: NXE. Product type: Walker, Mechanical, Poly Vinyl Chloride (Pvc). Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3825. This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance. Implant flag: N. Life-sustain/support flag: N.

Official code: NXF. Product type: Gas, Laser Generating. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4810. Special laser gas mixtures used as a lasing medium Implant flag: N. Life-sustain/support flag: N.

Official code: NXG. Product type: Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion. Official classification: Class III. Official category: Unknown. Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen. Implant flag: N. Life-sustain/support flag: N.

Official code: NXH. Product type: Nursing Pad, Cohesive Gel. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5630. Intended to relieve nipples that are sore and cracked from breast feeding. Implant flag: N. Life-sustain/support flag: N.

Official code: NXJ. Product type: Denture, Cosmetic Only. Official classification: Not classified. Official category: Unknown. Intended to improve an individual's appearance only. Not intended to assist in chewing food. Implant flag: N. Life-sustain/support flag: N.

Official code: NXM. Product type: Prosthesis, Eyelid Spacer/Graft, Biologic. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3130. For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid. Implant flag: Y. Life-sustain/support flag: N.

Official code: NXO. Product type: Calprotectin, Fecal. Official classification: Class II. Official category: Immunology. Regulation number: 866.5180. The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome. Implant flag: N. Life-sustain/support flag: N.

Official code: NXQ. Product type: Reminder, Medication. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules. The device may incorporate wireless communication. Implant flag: N. Life-sustain/support flag: N.

Official code: NXR. Product type: Fixation, Vision Training, Binocular. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1290. To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation. To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag. Implant flag: N. Life-sustain/support flag: N.

Official code: NXT. Product type: Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing. Official classification: Class III. Official category: Unknown. Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision. Implant flag: Y. Life-sustain/support flag: N.

Official code: NXV. Product type: Diagnostic Light, Soft Tissue Detector. Official classification: Class II. Official category: Dental. Regulation number: 872.6350. To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities Implant flag: N. Life-sustain/support flag: N.

Official code: NXW. Product type: Scaffold, Infrapopliteal, Absorbable. Official classification: Class III. Official category: Unknown. The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries. Implant flag: Y. Life-sustain/support flag: N.

Official code: NXX. Product type: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3700. The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6). Implant flag: N. Life-sustain/support flag: N.

Official code: NXZ. Product type: Dental Hygiene Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYC. Product type: Dental Prophylaxis Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYD. Product type: Endodontic Kit. Official classification: Class II. Official category: Dental. Regulation number: 872.3820. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYE. Product type: Fixture Mount Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.3980. Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYF. Product type: Gingival Retraction Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYG. Product type: Lapping Tool Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYH. Product type: Plaque Disclosing Kit. Official classification: Class II. Official category: Dental. Regulation number: 872.1740. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: NYI. Product type: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer. Official classification: Class II. Official category: Immunology. Regulation number: 866.6040. A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: NYK. Product type: Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma). Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1385. Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye. Implant flag: N. Life-sustain/support flag: N.

Official code: NYL. Product type: Handpiece, Air-Powered, Root Canal Irrigation. Official classification: Class I. Official category: Dental. Regulation number: 872.4200. To clean the root canal prior to filling and used for root canal irrigation. Implant flag: N. Life-sustain/support flag: N.

Official code: NYN. Product type: Stimulator, Electrical, Transcutaneous, For Arthritis. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Implant flag: N. Life-sustain/support flag: N.

Official code: NYO. Product type: Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use. Implant flag: N. Life-sustain/support flag: N.

Official code: NYQ. Product type: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer. Official classification: Class III. Official category: Unknown. This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy. Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a qualified pathologist. Implant flag: N. Life-sustain/support flag: N.

Official code: NYS. Product type: Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4015. A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing. The device consists of a textile substrate and permanently bound pdadmac. The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body. Implant flag: N. Life-sustain/support flag: N.

Official code: NYT. Product type: Prosthesis, Tracheal, Expandable, Polymeric. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3720. The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted. Implant flag: Y. Life-sustain/support flag: N.

Official code: NYU. Product type: Catheter, Hemodialysis, Implanted, Coated. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis. Implant flag: Y. Life-sustain/support flag: Y.

Official code: NYV. Product type: Gastrointestinal Motility System, Capsule. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1725. Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders. Implant flag: N. Life-sustain/support flag: N.

Official code: NYW. Product type: Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Nerve stimulation for relief of pain Implant flag: N. Life-sustain/support flag: N.

Official code: NYX. Product type: Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Electrical stimulation for aesthetic purposes Implant flag: N. Life-sustain/support flag: N.

Official code: NYY. Product type: Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5850. Used for muscle stimulation for rehabilitation. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area. Indicated for use as an adjunctive therapy in rehabilitation for medical purposes such as relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Implant flag: N. Life-sustain/support flag: N.

Official code: NYZ. Product type: Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5850. Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance. Implant flag: N. Life-sustain/support flag: N.

Official code: NZA. Product type: Accessories, Germicide, Cleaning, For Endoscopes. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: NZB. Product type: Quality Control Material, Genetics, Dna. Official classification: Class II. Official category: Microbiology. Regulation number: 866.5910. Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls. Implant flag: N. Life-sustain/support flag: N.

Official code: NZC. Product type: Stent, Urethral, Prostatic, Semi-Permanent. Official classification: Class III. Official category: Unknown. Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine. The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis. For short term use in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: NZD. Product type: Stretcher, Patient Restraint. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6900. Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations. Implant flag: N. Life-sustain/support flag: N.

Official code: NZE. Product type: Hyperthermia Monitor. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5900. Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions). Implant flag: N. Life-sustain/support flag: N.

Official code: NZF. Product type: Static Electricity-Emitting Device, Cosmetic Use. Official classification: Not classified. Official category: Unknown. Intended for relaxation and cosmetic use. Implant flag: N. Life-sustain/support flag: N.

Official code: NZG. Product type: Bassinet, Hospital. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5145. Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery. Implant flag: N. Life-sustain/support flag: N.

Official code: NZH. Product type: Medication Management System, Remote. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6315. A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic. Implant flag: N. Life-sustain/support flag: N.

Official code: NZJ. Product type: Respirator, N95, For Use By The General Public In Public Health Medical Emergencies. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6260. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids. Implant flag: N. Life-sustain/support flag: N.

Official code: NZK. Product type: Stimulator, Low Electric Field, Tumor Treatment. Official classification: Class III. Official category: Unknown. Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status. Implant flag: N. Life-sustain/support flag: Y.

Official code: NZP. Product type: Sealant, Microbial. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: NZS. Product type: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast. Implant flag: N. Life-sustain/support flag: N.

Official code: NZT. Product type: Dosimeter, Ionizing Radiation, Implanted. Official classification: Class II. Official category: Radiology. Regulation number: 892.5050. Verify radiation dose to organs from external radiation therapy. Implant flag: Y. Life-sustain/support flag: N.

Official code: NZU. Product type: Collector, Urine, Powered, Non Indwelling Catheter. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5250. For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair. Implant flag: N. Life-sustain/support flag: N.

Official code: NZW. Product type: Heparin, Vascular Access Flush. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use. Implant flag: N. Life-sustain/support flag: N.

Official code: NZX. Product type: Water, Vascular Access Flush. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use. Implant flag: N. Life-sustain/support flag: N.

Official code: NZY. Product type: Light, Lymphedema Reduction, Low Energy. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema. Implant flag: N. Life-sustain/support flag: N.

Official code: OAA. Product type: Aid, Visual, For Nausea. Official classification: Not classified. Official category: Unknown. To relieve the symptoms associated with motion sickness. Implant flag: N. Life-sustain/support flag: N.

Official code: OAB. Product type: Low Energy Direct Current Thermal Ablation System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Ablation of soft tissue Implant flag: N. Life-sustain/support flag: N.

Official code: OAC. Product type: Plethysmograph, Air Displacement For Body Composition Analysis. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass). Implant flag: N. Life-sustain/support flag: N.

Official code: OAD. Product type: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter. Official classification: Class III. Official category: Unknown. For the treatment of atrial flutter. Implant flag: N. Life-sustain/support flag: Y.

Official code: OAE. Product type: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation. Official classification: Class III. Official category: Unknown. For the treatment of atrial fibrillation. Implant flag: N. Life-sustain/support flag: Y.

Official code: OAF. Product type: Implant, Hearing, Active, Middle Ear, Totally Implanted. Official classification: Class III. Official category: Unknown. Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%. Implant flag: Y. Life-sustain/support flag: N.

Official code: OAG. Product type: Garment, Storage, Peritoneal Dialysis Catheter. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. To store the external peritoneal catheter portion between treatment sessions and to support, stabilize, and improve the care and cleanliness of the peritoneal catheter and reduce the need to use tape on the skin. Implant flag: N. Life-sustain/support flag: N.

Official code: OAH. Product type: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains. Implant flag: N. Life-sustain/support flag: N.

Official code: OAI. Product type: Assay, Enterovirus Nucleic Acid. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3225. Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus. Implant flag: N. Life-sustain/support flag: N.

Official code: OAJ. Product type: Catheter, Drainage, Intraoral/Extraoral. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones Implant flag: N. Life-sustain/support flag: N.

Official code: OAL. Product type: Exercise Equipment, Powered, Emg-Triggered. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.1375. To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education. Implant flag: N. Life-sustain/support flag: N.

Official code: OAM. Product type: Immunoassay, Insulin-Like Growth Factor Binding Protein-1. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1550. The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women. Implant flag: N. Life-sustain/support flag: N.

Official code: OAN. Product type: Orthosis, Cranial, Laser Scan. Official classification: Class II. Official category: Neurology. Regulation number: 882.5970. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. Implant flag: N. Life-sustain/support flag: N.

Official code: OAO. Product type: Cord Blood Processing System And Storage Container. Official classification: Class II. Official category: Hematology. Regulation number: 864.9900. A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is used as a functionally closed processing system by cord blood establishments. This device includes containers, other soft goods, and centrifugation systems for cord blood product concentration, and a final container for the cryopreservation and the storage of cord blood products. Implant flag: N. Life-sustain/support flag: N.

Official code: OAP. Product type: Laser, Comb, Hair. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5500. Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v Implant flag: N. Life-sustain/support flag: N.

Official code: OAQ. Product type: Electronic Media, Hyperacusis. Official classification: Not classified. Official category: Unknown. To improve sound tolerances. Implant flag: N. Life-sustain/support flag: N.

Official code: OAR. Product type: Injector, Vertebroplasty (Does Not Contain Cement). Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4200. Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). Implant flag: N. Life-sustain/support flag: N.

Official code: OAS. Product type: X-Ray, Tomography, Computed, Dental. Official classification: Class II. Official category: Radiology. Regulation number: 892.1750. Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth. Implant flag: N. Life-sustain/support flag: N.

Official code: OAT. Product type: Implant, Endosseous, Orthodontic. Official classification: Class II. Official category: Dental. Regulation number: 872.3640. It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implant flag: Y. Life-sustain/support flag: N.

Official code: OAU. Product type: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma. Official classification: Class II. Official category: Immunology. Regulation number: 866.6030. The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma. Implant flag: N. Life-sustain/support flag: N.

Official code: OAV. Product type: Mycophenolic Acid Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3840. An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OAW. Product type: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma. Official classification: HDE. Official category: Unknown. A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data. Implant flag: N. Life-sustain/support flag: N.

Official code: OAX. Product type: Plasmodium Spp. Detection Reagents. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3402. For the detection of plasmodium spp. Antigens in venous or capillary whole blood. To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plasmodium species. Implant flag: N. Life-sustain/support flag: N.

Official code: OAY. Product type: Light Source System, Diagnostic Endoscopic. Official classification: Class III. Official category: Unknown. A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test. Implant flag: N. Life-sustain/support flag: N.

Official code: OAZ. Product type: One-Way Air-Leak Valve. Official classification: HDE. Official category: Unknown. To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Implant flag: Y. Life-sustain/support flag: N.

Official code: OBA. Product type: Polymerizing, Neurovascular Embolization Material. Official classification: HDE. Official category: Unknown. The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OBB. Product type: Kit, Conception-Assist, Home Use. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5250. The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope. Implant flag: N. Life-sustain/support flag: N.

Official code: OBC. Product type: Occluder, Internal Vessel, Temporary. Official classification: Class III. Official category: Unknown. For temporarily occluding vessels during anastomosis procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: OBD. Product type: Barrier, Adhesion, Cardiovascular. Official classification: Class III. Official category: Unknown. Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region. Implant flag: Y. Life-sustain/support flag: N.

Official code: OBE. Product type: Anti-Ss-A 52 Autoantibodies. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis. Implant flag: N. Life-sustain/support flag: N.

Official code: OBF. Product type: Assay, Genotyping, Hepatitis C Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3170. In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes Implant flag: N. Life-sustain/support flag: N.

Official code: OBH. Product type: Monitor, Extracellular Fluid, Lymphedema, Extremity. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity) Implant flag: N. Life-sustain/support flag: N.

Official code: OBI. Product type: Catheter, Pressure Monitoring, Cardiac. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. To measure pressure within the cardiovascular system. Implant flag: N. Life-sustain/support flag: N.

Official code: OBJ. Product type: Catheter, Ultrasound, Intravascular. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology. Implant flag: N. Life-sustain/support flag: N.

Official code: OBK. Product type: Port, Protector/Cushion. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5965. Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports. Implant flag: N. Life-sustain/support flag: N.

Official code: OBL. Product type: Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height. Implant flag: Y. Life-sustain/support flag: N.

Official code: OBM. Product type: Cement, Bone, Vertebroplasty, Pre-Formed, Modular. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height. Implant flag: Y. Life-sustain/support flag: N.

Official code: OBN. Product type: Humidifier, Respiratory, Mask (Direct Patient Interface). Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5450. Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated. Implant flag: N. Life-sustain/support flag: N.

Official code: OBO. Product type: Tomography, Optical Coherence. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1570. Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases. Implant flag: N. Life-sustain/support flag: N.

Official code: OBP. Product type: Transcranial Magnetic Stimulator. Official classification: Class II. Official category: Neurology. Regulation number: 882.5805. A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder. Implant flag: N. Life-sustain/support flag: N.

Official code: OBR. Product type: Mouthguard, Over-The-Counter. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding. Implant flag: N. Life-sustain/support flag: N.

Official code: OBT. Product type: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OBV. Product type: Eating Disorder Conditioning Tool. Official classification: Class II. Official category: Neurology. Regulation number: 882.5060. A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: OBW. Product type: 11-Dehydro Thromboxane B2 Kit, Urinary. Official classification: Class II. Official category: Hematology. Regulation number: 864.5700. The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only. Implant flag: N. Life-sustain/support flag: N.

Official code: OBY. Product type: Condom, Female, Animal Tissue. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5330. A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: OBZ. Product type: Alpha-1-Antitrypsin Kit, Qualitative Phenotype. Official classification: Class II. Official category: Immunology. Regulation number: 866.5130. The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only. Implant flag: N. Life-sustain/support flag: N.

Official code: OCB. Product type: Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection. Official classification: Class III. Official category: Unknown. A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required. Implant flag: N. Life-sustain/support flag: Y.

Official code: OCC. Product type: Respiratory Virus Panel Nucleic Acid Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. Implant flag: N. Life-sustain/support flag: N.

Official code: OCE. Product type: Cultured Epithelial Autograft. Official classification: HDE. Official category: Unknown. Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OCF. Product type: Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Implant flag: N. Life-sustain/support flag: N.

Official code: OCG. Product type: Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented. Official classification: Class III. Official category: Orthopedic. Regulation number: 888.3410. Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head. Implant flag: Y. Life-sustain/support flag: N.

Official code: OCH. Product type: Oximeter, Infrared, Sporting, Aviation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise. Implant flag: N. Life-sustain/support flag: N.

Official code: OCI. Product type: Indicator, Physical/Chemical, Storage Temperature. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile. Implant flag: N. Life-sustain/support flag: N.

Official code: OCJ. Product type: Spinal Channeling Instrument, Vertebroplasty. Official classification: Class I. Official category: Orthopedic. Regulation number: 888.4540. Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions. Implant flag: N. Life-sustain/support flag: N.

Official code: OCK. Product type: Transurethral Occlusion Insert, Urinary Incontinence-Control, Female. Official classification: Class III. Official category: Unknown. Transurethral insert for urinary occlusion/control in women with urinary incontinence Implant flag: N. Life-sustain/support flag: N.

Official code: OCL. Product type: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue Implant flag: N. Life-sustain/support flag: N.

Official code: OCM. Product type: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation. Official classification: Class III. Official category: Unknown. Surgical cardiac ablation for the treatment of atrial fibrillation. Implant flag: N. Life-sustain/support flag: N.

Official code: OCN. Product type: Insulin Autoantibody Kit. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: OCO. Product type: Mouthguard, Migraine/Tension Headache. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity. Implant flag: N. Life-sustain/support flag: N.

Official code: OCQ. Product type: Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. For female urinary stress incontinence due to hypermobility Implant flag: N. Life-sustain/support flag: N.

Official code: OCR. Product type: Lung Sound Monitor. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1875. The lung sound monitor is intended for use in monitoring and recording lung sounds. Implant flag: N. Life-sustain/support flag: N.

Official code: OCS. Product type: Endoscopic Video Imaging System/Component, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To allow for visualization of body cavities through an endoscope by projecting images to a monitor. Implant flag: N. Life-sustain/support flag: N.

Official code: OCT. Product type: Anti Fog Solution And Accessories, Endoscopy. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To prevent, reduce or eliminate condensation (fog) on endoscopic lens. Implant flag: N. Life-sustain/support flag: N.

Official code: OCU. Product type: Endoscopic Storage Cover. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization. Implant flag: N. Life-sustain/support flag: N.

Official code: OCV. Product type: Endoscope Holder. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To hold endoscope in a desired position during procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: OCW. Product type: Endoscopic Tissue Approximation Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: OCX. Product type: Endoscopic Irrigation/Suction System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: OCY. Product type: Endoscopic Guidewire, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To provide access to gi or gu tract for the purpose of passing or exchanging other accessories. Implant flag: N. Life-sustain/support flag: N.

Official code: OCZ. Product type: Endoscopic Grasping/Cutting Instrument, Non-Powered. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope. Implant flag: N. Life-sustain/support flag: N.

Official code: ODA. Product type: Endoscopic Central Control Unit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command. Implant flag: N. Life-sustain/support flag: N.

Official code: ODB. Product type: Endoscopic Contamination Prevention Sheath. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To protect an endoscope from contamination by providing a barrier between the body and the endoscope. Implant flag: N. Life-sustain/support flag: N.

Official code: ODC. Product type: Endoscope Channel Accessory. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To give the endoscope channel additional or improved functionality. Implant flag: N. Life-sustain/support flag: N.

Official code: ODD. Product type: Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To identify stones, tumors, or narrowing in the biliary tree. Implant flag: N. Life-sustain/support flag: N.

Official code: ODE. Product type: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant. Implant flag: Y. Life-sustain/support flag: N.

Official code: ODF. Product type: Mini Endoscope, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: ODG. Product type: Endoscopic Ultrasound System, Gastroenterology-Urology. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: ODH. Product type: Implantable Bladder-Evacuation Electrical Stimulation System. Official classification: HDE. Official category: Unknown. To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable. Implant flag: Y. Life-sustain/support flag: N.

Official code: ODI. Product type: Administration Set Docking Station. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set. Implant flag: N. Life-sustain/support flag: N.

Official code: ODK. Product type: Refractive Corneal Implant. Official classification: HDE. Official category: Unknown. Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred. Implant flag: Y. Life-sustain/support flag: N.

Official code: ODN. Product type: Ultrafiltration-Controlled Nocturnal Dialysate Delivery System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5860. Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Implant flag: N. Life-sustain/support flag: Y.

Official code: ODP. Product type: Intervertebral Fusion Device With Bone Graft, Cervical. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3080. Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. Implant flag: Y. Life-sustain/support flag: N.

Official code: ODR. Product type: Electrosurgical Patient Return Electrode. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: ODS. Product type: Wound Covering (Composite Cultured Skin). Official classification: HDE. Official category: Unknown. Wound covering. Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities). Implant flag: Y. Life-sustain/support flag: N.

Official code: ODT. Product type: Tissue Adhesive, Aortic Aneurysmorrhaphy. Official classification: HDE. Official category: Unknown. For use as an adjunct in the surgical repair of thoracic aortic aneurysms. Implant flag: Y. Life-sustain/support flag: N.

Official code: ODU. Product type: Facial Implant. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3500. For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks. Implant flag: Y. Life-sustain/support flag: N.

Official code: ODV. Product type: Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System. Official classification: Class II. Official category: Hematology. Regulation number: 864.7750. An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity. Implant flag: N. Life-sustain/support flag: N.

Official code: ODW. Product type: Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3360. An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product. Implant flag: N. Life-sustain/support flag: N.

Official code: ODX. Product type: Autonomous Extracorporeal Blood Leak Detector/Alarm. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood. Implant flag: N. Life-sustain/support flag: N.

Official code: ODY. Product type: Tunneled Catheter Remover. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5970. To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body. Implant flag: N. Life-sustain/support flag: N.

Official code: OEA. Product type: Non-Surgical Gown. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4040. A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material Implant flag: N. Life-sustain/support flag: N.

Official code: OEB. Product type: Lung Computed Tomography System, Computer-Aided Detection. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR. Implant flag: N. Life-sustain/support flag: N.

Official code: OED. Product type: Antimicrobial Blood Pressure Cuff. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1120. Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure. Implant flag: N. Life-sustain/support flag: N.

Official code: OEE. Product type: Diagnostic Low Electric Field. Official classification: Class III. Official category: Unknown. As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation. Implant flag: N. Life-sustain/support flag: N.

Official code: OEG. Product type: Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. The device is intended as an aid in the diagnosis of bullous pemphigoid. Implant flag: N. Life-sustain/support flag: N.

Official code: OEH. Product type: Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3280. To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis. Implant flag: N. Life-sustain/support flag: N.

Official code: OEI. Product type: Drainage Catheter With Antibiotic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4780. A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump. Implant flag: N. Life-sustain/support flag: N.

Official code: OEJ. Product type: Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia Implant flag: N. Life-sustain/support flag: N.

Official code: OEK. Product type: Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia Implant flag: N. Life-sustain/support flag: N.

Official code: OEL. Product type: Laser, Benign Prostatic Hyperplasia. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia Implant flag: N. Life-sustain/support flag: N.

Official code: OEM. Product type: Human Metapneumovirus (Hmpv) Rna Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections. Implant flag: N. Life-sustain/support flag: N.

Official code: OEO. Product type: Automated Digital Image Manual Interpretation Microscope. Official classification: Class II. Official category: Hematology. Regulation number: 864.1860. The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: OEP. Product type: Influenza A Virus Subtype Differentiation Nucleic Acid Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza. Implant flag: N. Life-sustain/support flag: N.

Official code: OEQ. Product type: Angiography/Angioplasty Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OER. Product type: Angioscopic Valvulotome Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OES. Product type: Cardiac Catheterization Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OET. Product type: Cardioplegia Solution Administration Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4240. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OEU. Product type: Cardiopulmonary Bypass Catheter Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4210. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OEV. Product type: Cardiopulmonary Resuscitation Aid Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5915. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OEW. Product type: Tracking, Soft Tissue, Intraoperative. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. Implant flag: N. Life-sustain/support flag: Y.

Official code: OEX. Product type: Cardiovascular Catheter Sheath Introducer Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OEZ. Product type: Cardiovascular Procedure Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFA. Product type: Cardiovascular Surgical Instruments Tray. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.4500. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFB. Product type: Catheter Guide Wire Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1330. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFC. Product type: Catheter Introducer Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFD. Product type: Catheter Introducer Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. The convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFE. Product type: Central Venous Blood Pressure Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1140. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFF. Product type: Central Venous Catheter Tray. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1140. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFG. Product type: Ct Biopsy Tray. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4075. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFH. Product type: Digital Angiography Tray. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFI. Product type: Laser Blood Flow Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFJ. Product type: Lead Introducer Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFK. Product type: Percutaneous Atrial Catheter Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFL. Product type: Percutaneous Sheath Introducer Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFM. Product type: Phlebotomy Blood Collection Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2750. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFN. Product type: Winged Intravenous Catheterization Kit. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFO. Product type: Airway Suction Kit. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6810. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFP. Product type: Anesthesia Breathing Circuit Kit (Adult & Pediatric). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5240. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFQ. Product type: Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFR. Product type: Tracheobronchial Suction Catheter Kit. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6810. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFS. Product type: Tracheal Suction Set. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6810. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFT. Product type: Spinal Epidural Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFU. Product type: Spinal Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFV. Product type: Regional Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFW. Product type: Restorative Instrument And Component Tray. Official classification: Class II. Official category: Dental. Regulation number: 872.3690. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFX. Product type: General Purpose Dental Tray. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFY. Product type: Dental Implant Surgical Tray. Official classification: Class I. Official category: Dental. Regulation number: 872.3980. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OFZ. Product type: Blood Specimen Collection Kit (Excludes Hiv Testing). Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.1100. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OGA. Product type: Brachial Plexus Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5140. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OGB. Product type: Caudal Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5140. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OGC. Product type: Continuous Brachial Plexus Block Tray. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5150. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OGD. Product type: Custom Anesthesia Tray. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGE. Product type: Epidural Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGF. Product type: Glossopharyngeal Anesthesia Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5120. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGG. Product type: Humidifier Nebulizer Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5450. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGH. Product type: Laryngoscope Kit. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5540. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGI. Product type: Nasal Endotracheal Tube Holder Kit. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5770. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGJ. Product type: Nerve Block Tray. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5140. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGK. Product type: Orotracheal Intubation Guide Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1400. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGL. Product type: Oxygen Administration Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5655. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OGO. Product type: Intraocular Pressure Lowering Implant. Official classification: Class III. Official category: Unknown. An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment. Implant flag: Y. Life-sustain/support flag: N.

Official code: OGP. Product type: Cricothyrotomy Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5800. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OGQ. Product type: Ear Irrigation Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6960. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OGR. Product type: Ear, Nose, And Throat Surgical Tray. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OGS. Product type: Myringotomy Procedure Kit. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3880. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OGT. Product type: Oral Irrigation Kit. Official classification: Class I. Official category: Dental. Regulation number: 872.6510. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OGU. Product type: Pierced Ear/Entry Cleaning Tray. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. Contents typically includes: Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OGV. Product type: Tracheostomy Cleaning Tray. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5800. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OGW. Product type: Tracheostomy Kit. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5800. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OGZ. Product type: Catheter, Intravascular, Plaque Morphology Evaluation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques. Implant flag: N. Life-sustain/support flag: N.

Official code: OHA. Product type: Heart Valve, More Than Minimally Manipulated Allograft. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions. Implant flag: Y. Life-sustain/support flag: N.

Official code: OHC. Product type: Obstetrical Vacuum Delivery Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4340. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHD. Product type: Gynecological Laparoscopic Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHE. Product type: Forensic Evidence Sexual Assault Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1630. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHF. Product type: Culdocentesis Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1640. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHG. Product type: Circumcision Tray. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHH. Product type: Breast Pump Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5160. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHI. Product type: Orthosis, Foot Drop. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis. Implant flag: N. Life-sustain/support flag: N.

Official code: OHL. Product type: Pap Smear Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHM. Product type: Cesarean Section Tray. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHO. Product type: First Aid Kit Without Drug. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHP. Product type: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea. Official classification: Class II. Official category: Dental. Regulation number: 872.5570. Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea. Implant flag: N. Life-sustain/support flag: N.

Official code: OHQ. Product type: Multi-Analyte Controls Unassayed. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls. Implant flag: N. Life-sustain/support flag: N.

Official code: OHR. Product type: Catheter Care Tray. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OHS. Product type: Light Based Over The Counter Wrinkle Reduction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided. Implant flag: N. Life-sustain/support flag: N.

Official code: OHT. Product type: Light Based Over-The-Counter Hair Removal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Over-the-counter device uses thermal energy to kill hair follicles for hair removal. Implant flag: N. Life-sustain/support flag: N.

Official code: OHV. Product type: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4590. A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use. Implant flag: N. Life-sustain/support flag: N.

Official code: OHW. Product type: Burr, Corneal, Battery Powered, Rust Ring Removal. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal. Implant flag: N. Life-sustain/support flag: N.

Official code: OHX. Product type: Burr, Corneal, Ac-Powered, Rust Ring Removal. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4070. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal. Implant flag: N. Life-sustain/support flag: N.

Official code: OHY. Product type: Pill Crusher/Cutter. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6430. A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting. Implant flag: N. Life-sustain/support flag: N.

Official code: OHZ. Product type: Urine Transport Kit (Excludes Hiv Testing). Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIA. Product type: Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing). Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIB. Product type: Blood And Urine Collection Kit (Excludes Hiv Testing). Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIC. Product type: Blood Alcohol Kit (Excludes Hiv Testing). Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OID. Product type: Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing). Official classification: Class I. Official category: Microbiology. Regulation number: 866.2900. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIE. Product type: Urine Collection Kit (Excludes Hiv Testing). Official classification: Class I. Official category: Pathology. Regulation number: 864.3250. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIF. Product type: Tyrosine Phosphatase (Ia-2) Autoantibody Assay. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). Implant flag: N. Life-sustain/support flag: N.

Official code: OIG. Product type: Powder-Free Guayle Rubber Examination Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. Implant flag: N. Life-sustain/support flag: N.

Official code: OIH. Product type: Yersinia Spp. Reagents. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens. They are indicated for use as an aid in the laboratory of diagnosis of plague. Implant flag: N. Life-sustain/support flag: N.

Official code: OII. Product type: Arthrogram Tray. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIJ. Product type: Biopsy Needle Guide Kit. Official classification: Class II. Official category: Radiology. Regulation number: 892.1560. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIK. Product type: Radiology Dental Tray. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIL. Product type: Discography Kit. Official classification: Class II. Official category: Radiology. Regulation number: 892.1730. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIM. Product type: Mri Disposable Kit. Official classification: Class II. Official category: Radiology. Regulation number: 892.1000. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIN. Product type: Prostate Seeding Kit. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIO. Product type: Radiographic Contrast Tray. Official classification: Class II. Official category: Radiology. Regulation number: 892.1680. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIP. Product type: Radiology-Diagnostic Kit. Official classification: Class II. Official category: Radiology. Regulation number: 892.1680. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OIR. Product type: Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator. Official classification: Class III. Official category: Unknown. The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OIS. Product type: Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3045. To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation. Implant flag: Y. Life-sustain/support flag: N.

Official code: OIU. Product type: Test, Epithelial Ovarian Tumor Associated Antigen (He4). Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OIV. Product type: Dental Amalgam. Official classification: Class II. Official category: Dental. Regulation number: 872.3070. Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth Implant flag: N. Life-sustain/support flag: N.

Official code: OIW. Product type: Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified clinician. The test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice. Implant flag: N. Life-sustain/support flag: N.

Official code: OIY. Product type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3560. Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use. Implant flag: Y. Life-sustain/support flag: N.

Official code: OIZ. Product type: Foot Examination Tool For Inflammatory Changes. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. The device will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. Intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state. Implant flag: N. Life-sustain/support flag: N.

Official code: OJA. Product type: Intravenous Extension Tubing Set. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJB. Product type: Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation. Implant flag: Y. Life-sustain/support flag: N.

Official code: OJE. Product type: Right Ventricular Bypass (Assist) Device. Official classification: HDE. Official category: Unknown. To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure. Implant flag: N. Life-sustain/support flag: N.

Official code: OJF. Product type: Hysterectomy Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJG. Product type: Neurological Tray. Official classification: Class I. Official category: Neurology. Regulation number: 882.4525. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJH. Product type: Orthopedic Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJI. Product type: Burn Kit With Drug. Official classification: Not classified. Official category: Unknown. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJJ. Product type: Burn Kit Without Drug. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4022. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJK. Product type: Eye Tray. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4790. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJL. Product type: Insulin Vial Protector/Holder. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. The device is intended to protect an insulin vial or vials Implant flag: N. Life-sustain/support flag: N.

Official code: OJM. Product type: Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation. Implant flag: Y. Life-sustain/support flag: N.

Official code: OJN. Product type: Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test. Official classification: Class III. Official category: Unknown. For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations. Implant flag: N. Life-sustain/support flag: N.

Official code: OJO. Product type: Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria. Official classification: Not classified. Official category: Unknown. Enzyme linked immunosorbent assay (elisa) system intended for in vitro diagnostic use to qualitatively detect the presence of lipoarabinomannan (lam) antigen of mycobacteria in human urine as an aid in the diagnosis of current mycobacterial infection in hiv positive patients with systems of tuberculosis. Implant flag: N. Life-sustain/support flag: N.

Official code: OJP. Product type: Orthopedic Computer Controlled Surgical System. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA). Implant flag: N. Life-sustain/support flag: N.

Official code: OJQ. Product type: Cardiac Allograft Gene Expression Profiling Test System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 862.1163. In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment. Implant flag: N. Life-sustain/support flag: N.

Official code: OJR. Product type: Vacuum Powered Body Fluid Collection Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4780. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJS. Product type: Tourniquet Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5900. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OJT. Product type: Aspiration Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OJU. Product type: Skin Prep Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OJV. Product type: Single Use Instrument Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OJW. Product type: Shave Prep Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OJX. Product type: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode. Official classification: Class III. Official category: Unknown. Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OJY. Product type: Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3236. A device to detect or measure nucleic acid from viruses associated with head and neck cancers is an in vitro diagnostic test for prescription use in the detection of viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer. The test result is intended to be used in conjunction with other clinical information to aid in assessing the clinical status of virus-associated head and neck cancers and/or the likelihood that head and neck cancer is present. Implant flag: N. Life-sustain/support flag: N.

Official code: OJZ. Product type: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde. Official classification: HDE. Official category: Unknown. Device type: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest. Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics. Revision spine surgery to treat pseudarthrosis. Implant flag: Y. Life-sustain/support flag: N.

Official code: OKC. Product type: Implanted Subcutaneous Securement Catheter. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5970. Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site. Implant flag: Y. Life-sustain/support flag: N.

Official code: OKD. Product type: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion. Official classification: HDE. Official category: Unknown. Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics. Implant flag: Y. Life-sustain/support flag: N.

Official code: OKE. Product type: Port Introducer Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5965. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKF. Product type: Body Fluid Disposal Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKG. Product type: Body Fluid Clean Up Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKH. Product type: Body Fluids Barrier Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKI. Product type: Emergency Response Safety Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKJ. Product type: Light Based Treatment For Cold Sores Herpes Simplex Virus-1. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4860. Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization. Implant flag: N. Life-sustain/support flag: N.

Official code: OKL. Product type: Intravascular Administration Set, Automated Air Removal System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5445. An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid. Implant flag: N. Life-sustain/support flag: N.

Official code: OKM. Product type: Antibodies, Outer-Membrane Proteins. Official classification: Class II. Official category: Immunology. Regulation number: 866.5785. For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease. Implant flag: N. Life-sustain/support flag: N.

Official code: OKN. Product type: Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy. Official classification: Class III. Official category: Unknown. To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug. For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors. Implant flag: N. Life-sustain/support flag: N.

Official code: OKO. Product type: Negative Pressure Wound Therapy Non-Powered Suction Apparatus. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4683. A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Implant flag: N. Life-sustain/support flag: N.

Official code: OKP. Product type: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache. Official classification: Class II. Official category: Neurology. Regulation number: 882.5808. Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache. Implant flag: N. Life-sustain/support flag: N.

Official code: OKR. Product type: Ventricular Bypass (Assist) Device. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3545. A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body. Implant flag: N. Life-sustain/support flag: N.

Official code: OKS. Product type: Lacrimal Stents And Intubation Sets. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant. Implant flag: Y. Life-sustain/support flag: N.

Official code: OKU. Product type: Emergency Obstetrical Kit. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OKV. Product type: Obstetrical Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4520. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OKW. Product type: Seminal Fluid Collection Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance Implant flag: N. Life-sustain/support flag: N.

Official code: OKX. Product type: Trocar Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1720. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKY. Product type: Cytology Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OKZ. Product type: Endometrial Sampling Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1175. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OLC. Product type: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure. Implant flag: Y. Life-sustain/support flag: N.

Official code: OLD. Product type: Internal Polymerase Chain Reaction Control, Not Assay Specific. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1660. Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. Implant flag: N. Life-sustain/support flag: N.

Official code: OLF. Product type: Medevac Use Oxygen Generator. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5440. A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW. Implant flag: N. Life-sustain/support flag: Y.

Official code: OLH. Product type: Orchidometer. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant. Implant flag: N. Life-sustain/support flag: N.

Official code: OLI. Product type: Fat Reducing Low Level Laser. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5400. Non-invasive reduction in fat layer for body contouring Implant flag: N. Life-sustain/support flag: N.

Official code: OLK. Product type: Pulse Oximeter For Over-The-Counter Use. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring Implant flag: N. Life-sustain/support flag: N.

Official code: OLL. Product type: Septal Stapler/Absorbable Staples. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4750. To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction. Implant flag: Y. Life-sustain/support flag: N.

Official code: OLM. Product type: Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd). Official classification: HDE. Official category: Unknown. The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant Obsessive Compulsive Disorder (OCD) in adult patients who have failed at least three Selective Serotonin Reuptake Inhibitors (SSRIs). Implant flag: Y. Life-sustain/support flag: N.

Official code: OLO. Product type: Orthopedic Stereotaxic Instrument. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW. Implant flag: N. Life-sustain/support flag: N.

Official code: OLP. Product type: Over-The-Counter Powered Light Based Laser For Acne. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris. Implant flag: N. Life-sustain/support flag: N.

Official code: OLQ. Product type: Cross-Sectional Mammographic Xray System. Official classification: Class III. Official category: Unknown. Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: OLR. Product type: Oral Wound Dressing. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ. Implant flag: N. Life-sustain/support flag: N.

Official code: OLS. Product type: Oral Wound Dressing W/Drug And/Or Biologic. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per se to mgq. Implant flag: N. Life-sustain/support flag: N.

Official code: OLT. Product type: Non-Normalizing Quantitative Electroencephalograph Software. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user. Implant flag: N. Life-sustain/support flag: N.

Official code: OLU. Product type: Normalizing Quantitative Electroencephalograph Software. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user. Implant flag: N. Life-sustain/support flag: N.

Official code: OLV. Product type: Standard Polysomnograph With Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data. Implant flag: N. Life-sustain/support flag: N.

Official code: OLW. Product type: Index-Generating Electroencephalograph Software. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user. Implant flag: N. Life-sustain/support flag: N.

Official code: OLX. Product type: Source Localization Software For Electroencephalograph Or Magnetoencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization Implant flag: N. Life-sustain/support flag: N.

Official code: OLY. Product type: Magnetoencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy. Implant flag: N. Life-sustain/support flag: N.

Official code: OLZ. Product type: Automatic Event Detection Software For Polysomnograph With Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user Implant flag: N. Life-sustain/support flag: N.

Official code: OMA. Product type: Amplitude-Integrated Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner). Implant flag: N. Life-sustain/support flag: N.

Official code: OMB. Product type: Automatic Event Detection Software For Full-Montage Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user Implant flag: N. Life-sustain/support flag: N.

Official code: OMC. Product type: Reduced- Montage Standard Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes Implant flag: N. Life-sustain/support flag: N.

Official code: OMD. Product type: Cutaneous Tissue Adhesive With Mesh. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4011. For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures. Implant flag: N. Life-sustain/support flag: N.

Official code: OME. Product type: Extracorporeal Shock Wave Treatment. Official classification: Class III. Official category: Unknown. For use for extracorporeal shock wave treatment of atrophic nonunion fractures. The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal. Implant flag: N. Life-sustain/support flag: N.

Official code: OMF. Product type: Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5970. When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure. Implant flag: Y. Life-sustain/support flag: N.

Official code: OMG. Product type: Antisera, Fluorescent, Human Metapneumovirus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. Implant flag: N. Life-sustain/support flag: N.

Official code: OMH. Product type: Pericardial Patch To Facilitate Revision Surgeries. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3470. Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OMI. Product type: Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors. Implant flag: N. Life-sustain/support flag: N.

Official code: OMJ. Product type: Chest X-Ray Computer Aided Detection. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review. Implant flag: N. Life-sustain/support flag: N.

Official code: OMM. Product type: Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr. Official classification: Class II. Official category: Hematology. Regulation number: 864.7280. In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia. Implant flag: N. Life-sustain/support flag: N.

Official code: OMN. Product type: C. Difficile Nucleic Acid Amplification Test Assay. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2660. In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OMP. Product type: Negative Pressure Wound Therapy Powered Suction Pump. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4780. For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Implant flag: N. Life-sustain/support flag: N.

Official code: OMR. Product type: Vessel Guard Or Cover. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3470. These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels. Implant flag: Y. Life-sustain/support flag: N.

Official code: OMS. Product type: Novel Influenza A Virus, A/H5 Ns1 Protein. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3332. Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza. Implant flag: N. Life-sustain/support flag: N.

Official code: OMT. Product type: Absorbable Lung Biopsy Plug. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4755. A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed. Implant flag: Y. Life-sustain/support flag: N.

Official code: OMV. Product type: Ultrasonic Body Composition Analyzer. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively. Implant flag: N. Life-sustain/support flag: N.

Official code: OMW. Product type: Adhesive Backed Thermal Skin Patches. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5710. Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns. Implant flag: N. Life-sustain/support flag: N.

Official code: OMX. Product type: High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis. Official classification: HDE. Official category: Unknown. For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage. Implant flag: Y. Life-sustain/support flag: N.

Official code: OMZ. Product type: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. Implant flag: N. Life-sustain/support flag: N.

Official code: ONA. Product type: Computer Assisted Hair Harvesting System. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation. Implant flag: N. Life-sustain/support flag: N.

Official code: ONB. Product type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting. Implant flag: N. Life-sustain/support flag: N.

Official code: OND. Product type: Osmolality Of Tears. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1540. To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. Implant flag: N. Life-sustain/support flag: N.

Official code: ONE. Product type: Powered Light Based Non-Laser Surgical Instrument. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light. Implant flag: N. Life-sustain/support flag: N.

Official code: ONF. Product type: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light. Implant flag: N. Life-sustain/support flag: N.

Official code: ONG. Product type: Powered Laser Surgical Instrument With MicrobeamFractional Output. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light. Implant flag: N. Life-sustain/support flag: N.

Official code: ONJ. Product type: Dissolvable Gel For Preventing Ureteral Stone Migration. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4680. For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: ONK. Product type: Oral Lubricant. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6375. An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: ONL. Product type: Conformal Brachytherapy Source. Official classification: Class II. Official category: Radiology. Regulation number: 892.5730. The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device. Implant flag: N. Life-sustain/support flag: N.

Official code: ONM. Product type: Radiant Infant Warmer Cabinet. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5130. The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer. Implant flag: N. Life-sustain/support flag: N.

Official code: ONN. Product type: Intraoperative Orthopedic Joint Assessment Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Measurement and interpretation of orthopedic joint information. Implant flag: N. Life-sustain/support flag: N.

Official code: ONO. Product type: Neurosurgical Laser With Mr Thermography. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery. Implant flag: N. Life-sustain/support flag: N.

Official code: ONQ. Product type: Electrosurgical Coagulation For Aesthetic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. For the treatment of spider vein or telangiectasia by thermocoagulation. Implant flag: N. Life-sustain/support flag: N.

Official code: ONT. Product type: N95 Respirator With Antimicrobial/Antiviral Agent. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: ONU. Product type: Drug-Eluting Peripheral Transluminal Angioplasty Catheter. Official classification: Class III. Official category: Unknown. A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral. Implant flag: N. Life-sustain/support flag: N.

Official code: ONV. Product type: Electrical Impedance Spectrometer. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.1820. An electrical impedance spectrometer is a prescription device that measures and analyzes electrical impedance properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma. Implant flag: N. Life-sustain/support flag: N.

Official code: ONW. Product type: Hemodialysis System For Home Use. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5860. To treat and provide hemodialysis therapy at home for chronic renal failure patients. Implant flag: N. Life-sustain/support flag: N.

Official code: ONX. Product type: Ovarian Adnexal Mass Assessment Score Test System. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 866.6050. An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources. Implant flag: N. Life-sustain/support flag: N.

Official code: ONY. Product type: Oral Removable Retainer For Weight Management. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5981. A removable oral device used during meals to limit food intake. Implant flag: N. Life-sustain/support flag: N.

Official code: ONZ. Product type: Mechanical Ventilator. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician, Implant flag: N. Life-sustain/support flag: N.

Official code: OOA. Product type: Hemorrhoid Prevention Pressure Wedge. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5200. Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery. Implant flag: N. Life-sustain/support flag: N.

Official code: OOB. Product type: Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter. Official classification: Class III. Official category: Unknown. A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis. Implant flag: N. Life-sustain/support flag: N.

Official code: OOD. Product type: Surgical Film. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OOE. Product type: Ophthalmic Femtosecond Laser. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4390. Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery. Implant flag: N. Life-sustain/support flag: N.

Official code: OOF. Product type: Cryogenic Cord Blood Storage Container. Official classification: Class II. Official category: Hematology. Regulation number: 864.9900. Intended as a final container for the cryopreservation and the storage of cord blood products. A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen. Implant flag: N. Life-sustain/support flag: N.

Official code: OOG. Product type: Knee Arthroplasty Implantation System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3560. Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. Implant flag: N. Life-sustain/support flag: N.

Official code: OOI. Product type: Real Time Nucleic Acid Amplification System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. Implant flag: N. Life-sustain/support flag: N.

Official code: OOK. Product type: Dermal Cooling Pack/Vacuum/Massager. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4340. The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas. Implant flag: N. Life-sustain/support flag: N.

Official code: OOL. Product type: Electronic Depth Gauge. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: OOU. Product type: Parainfluenza Multiplex Nucleic Acid Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: OOW. Product type: Applicator For Rectal Suppository. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. Intended for use in the insertion of suppositories into the rectum Implant flag: N. Life-sustain/support flag: N.

Official code: OOX. Product type: Automated Occult Blood Analyzer. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding. Implant flag: N. Life-sustain/support flag: N.

Official code: OOY. Product type: Bronchial Thermoplasty System. Official classification: Class III. Official category: Unknown. Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways. Implant flag: N. Life-sustain/support flag: N.

Official code: OPC. Product type: Powder-Free Polychloroprene Patient Examination Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. Implant flag: N. Life-sustain/support flag: N.

Official code: OPH. Product type: Radiation Attenuating Medical Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: OPJ. Product type: Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: OPL. Product type: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors. Implant flag: N. Life-sustain/support flag: N.

Official code: OPM. Product type: Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors. Implant flag: N. Life-sustain/support flag: N.

Official code: OPN. Product type: Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases Implant flag: N. Life-sustain/support flag: N.

Official code: OPP. Product type: Pump, Infusion, Insulin Bolus. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus. Implant flag: N. Life-sustain/support flag: N.

Official code: OPR. Product type: Intrasaccular Flow Disruption Device. Official classification: Class III. Official category: Unknown. An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach. Implant flag: Y. Life-sustain/support flag: N.

Official code: OPT. Product type: Infrared Hematoma Detector. Official classification: Class II. Official category: Ophthalmic. Regulation number: 882.1935. To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas. Implant flag: N. Life-sustain/support flag: N.

Official code: OPX. Product type: Immunoglobulin A Kappa Heavy & Light Chain Combined. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OPY. Product type: Igal Heavy & Light Chain Combined. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Intended for the in-vitro quantification of iga lambda concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OQB. Product type: Intervertebral Body Graft Containment Device. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3085. An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: OQG. Product type: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3358. 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use. Implant flag: Y. Life-sustain/support flag: N.

Official code: OQH. Product type: Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3350. 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use. Implant flag: Y. Life-sustain/support flag: N.

Official code: OQI. Product type: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3353. 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use. Implant flag: Y. Life-sustain/support flag: N.

Official code: OQL. Product type: Mesh, Surgical, Deployment Balloon. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias. Implant flag: N. Life-sustain/support flag: N.

Official code: OQO. Product type: Herpes Simplex Virus Nucleic Acid Amplification Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3305. A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: OQQ. Product type: Diagnostic Ultrasonic Transducer, Robotic. Official classification: Class II. Official category: Radiology. Regulation number: 892.1570. Diagnostic ultrasonic imaging or monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: OQS. Product type: Laboratory Developed Test. Official classification: Not classified. Official category: Unknown. Laboratory Developed Test Implant flag: N. Life-sustain/support flag: N.

Official code: OQT. Product type: Prostate Lesion, Documentation, System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.2050. Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination. Implant flag: N. Life-sustain/support flag: N.

Official code: OQU. Product type: Airway Monitoring System. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5730. The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip Implant flag: N. Life-sustain/support flag: N.

Official code: OQW. Product type: 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3332. 2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens Implant flag: N. Life-sustain/support flag: N.

Official code: OQX. Product type: Self-Contained Blood Grouping. Official classification: Class II. Official category: Hematology. Regulation number: 864.9175. Intended for single use for individual blood group determination for educational and informational purposes Implant flag: N. Life-sustain/support flag: N.

Official code: OQY. Product type: Intrauterine Tamponade Balloon. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. provides temporary control or reduction of postpartum uterine bleeding Implant flag: N. Life-sustain/support flag: N.

Official code: OQZ. Product type: Anti-Mutated Citrullinated Vimentin Igg. Official classification: Class II. Official category: Immunology. Regulation number: 866.5775. For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: ORA. Product type: Breast Milk-Alcohol Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3040. Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk. Implant flag: N. Life-sustain/support flag: N.

Official code: ORC. Product type: Air Filter Portable Apparatus. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5070. The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: ORD. Product type: Optical Coherence Tomography, Intravascular Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: ORG. Product type: Platelet And Plasma Separator For Bone Graft Handling. Official classification: Class II. Official category: Hematology. Regulation number: 864.9245. Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics. Implant flag: N. Life-sustain/support flag: N.

Official code: ORH. Product type: Lamotrigine Assay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Implant flag: N. Life-sustain/support flag: N.

Official code: ORI. Product type: Levetiracetam Assay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. For the quantitative determination of levetiracetam in human serum or plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: ORK. Product type: Laser Assisted Lipolysis. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Intended to be used for laser assisted lipolysis Implant flag: N. Life-sustain/support flag: N.

Official code: ORL. Product type: Whole Blood Pre-Treatment T-Cell Enrichment Reagent. Official classification: Class III. Official category: Unknown. The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C). Implant flag: N. Life-sustain/support flag: N.

Official code: ORQ. Product type: Mesh, Surgical, Deployer. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair). Implant flag: N. Life-sustain/support flag: N.

Official code: ORR. Product type: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite. Implant flag: N. Life-sustain/support flag: N.

Official code: ORT. Product type: Burst Suppression Detection Software For Electroencephalograph. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user. Implant flag: N. Life-sustain/support flag: N.

Official code: ORW. Product type: N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6260. A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: ORY. Product type: Tongue Suspension System. Official classification: Class II. Official category: Dental. Regulation number: 872.5570. Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. Implant flag: Y. Life-sustain/support flag: N.

Official code: ORZ. Product type: Eyelid Thermal Pulsation System. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5200. Therapeutic application of heat and massage to the eyelids. Implant flag: N. Life-sustain/support flag: N.

Official code: OSD. Product type: Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5670. Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity Implant flag: N. Life-sustain/support flag: N.

Official code: OSE. Product type: Patient Specific Manual Navigation System. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Intended for defining implant alignment relative to a patient's anatomy. Implant flag: N. Life-sustain/support flag: N.

Official code: OSF. Product type: Patient Specific Manual Orthopedic Stereotaxic System. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy. Implant flag: N. Life-sustain/support flag: N.

Official code: OSG. Product type: Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch. Official classification: Class II. Official category: Neurology. Regulation number: 882.5894. Relief / Reduction of Mosquito Bite Itch Implant flag: N. Life-sustain/support flag: N.

Official code: OSH. Product type: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis. Implant flag: Y. Life-sustain/support flag: N.

Official code: OSI. Product type: Bariatric Bed. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5100. A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width. Implant flag: N. Life-sustain/support flag: N.

Official code: OSK. Product type: Anti-Glutamate Receptor (Type Nmda) Ifa. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. Used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings. Implant flag: N. Life-sustain/support flag: N.

Official code: OSL. Product type: Control, Fecal Occult Blood. Official classification: Class II. Official category: Hematology. Regulation number: 864.6550. Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices. Implant flag: N. Life-sustain/support flag: N.

Official code: OSM. Product type: Hearing Aid, Air-Conduction With Wireless Technology, Prescription. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3305. A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid. Implant flag: N. Life-sustain/support flag: N.

Official code: OSN. Product type: Software For Diagnosis/Treatment. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions Implant flag: Y. Life-sustain/support flag: N.

Official code: OSP. Product type: Uterine Electromyographic Monitor. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.2720. The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy. Implant flag: N. Life-sustain/support flag: N.

Official code: OSR. Product type: Pacemaker/Icd/Crt Non-Implanted Components. Official classification: Class III. Official category: Unknown. Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider. Implant flag: Y. Life-sustain/support flag: N.

Official code: OSU. Product type: Dengue Serological Reagents. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3945. Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: OSV. Product type: Insufflator, Endoscopic Vessel Harvesting. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1730. To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated. Implant flag: N. Life-sustain/support flag: N.

Official code: OSX. Product type: Galectin-3 In Vitro Diagnostic Assay. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1117. Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. Implant flag: N. Life-sustain/support flag: N.

Official code: OSZ. Product type: Antimicrobial Keyboard. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6600. To reduce microbial populations Implant flag: N. Life-sustain/support flag: N.

Official code: OTA. Product type: Mass Spectrometer For Clinical Multiplex Test Systems. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. A mass spectrometer for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature. Implant flag: N. Life-sustain/support flag: N.

Official code: OTD. Product type: Endovascular Suturing System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3460. Provides fixation and sealing between and endovascular graft and the native artery. Implant flag: Y. Life-sustain/support flag: N.

Official code: OTE. Product type: Digital Breast Tomosynthesis. Official classification: Class III. Official category: Unknown. To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: OTF. Product type: Gabapentin Assay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3350. Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin. Implant flag: N. Life-sustain/support flag: N.

Official code: OTG. Product type: Non-Sars Coronavirus Multiplex Nucleic Acid Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: OTJ. Product type: Laparoscopic Single Port Access Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. Implant flag: N. Life-sustain/support flag: N.

Official code: OTK. Product type: Wound Drain Catheter System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4780. For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: OTL. Product type: Femtosecond Laser System For Refractive Correction. Official classification: Class III. Official category: Unknown. Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea Implant flag: N. Life-sustain/support flag: N.

Official code: OTM. Product type: Mesh, Surgical, For Stress Urinary Incontinence, Male. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. surgical treatment of male stress urinary incontinence post-prostatectomy Implant flag: Y. Life-sustain/support flag: N.

Official code: OTN. Product type: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility Implant flag: Y. Life-sustain/support flag: N.

Official code: OTO. Product type: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy. Implant flag: Y. Life-sustain/support flag: N.

Official code: OTP. Product type: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5980. Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally Implant flag: Y. Life-sustain/support flag: N.

Official code: OTQ. Product type: Research Use Only/Hematology Devices. Official classification: Not classified. Official category: Unknown. For research use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: OTR. Product type: Research Use Only/Immunology Devices. Official classification: Not classified. Official category: Unknown. For research use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: OTT. Product type: Research Use Only/Microbiology. Official classification: Not classified. Official category: Unknown. For research use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: OTU. Product type: Research Use Only/Pathology. Official classification: Not classified. Official category: Unknown. For research use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: OTV. Product type: Research Use Only/Clinical Chemistry Devices. Official classification: Not classified. Official category: Unknown. For research use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: OTW. Product type: Research Use Only/Clinical Toxicology. Official classification: Not classified. Official category: Unknown. For research use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: OTX. Product type: Foot Wrap For Treating Restless Leg Syndrome Symptoms. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5760. Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system. Implant flag: N. Life-sustain/support flag: N.

Official code: OTZ. Product type: Graft Insertion Instrument For Endothelial Keratoplasty. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4300. A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed. Implant flag: N. Life-sustain/support flag: N.

Official code: OUB. Product type: Instrument For Treatment Of Hyperhidrosis. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Soft-tissue coagulation Implant flag: N. Life-sustain/support flag: N.

Official code: OUC. Product type: Norovirus Serological Reagent. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3395. Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks. Implant flag: N. Life-sustain/support flag: N.

Official code: OUE. Product type: Micro Total Analysis Instrument System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system. Implant flag: N. Life-sustain/support flag: N.

Official code: OUF. Product type: Everolimus Immunoassay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3840. To quantify everolimus in whole blood. Implant flag: N. Life-sustain/support flag: N.

Official code: OUG. Product type: Medical Device Data System. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6310. A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: OUH. Product type: Skin Resurfacing Rf Applicator. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Skin resurfacing Implant flag: N. Life-sustain/support flag: N.

Official code: OUJ. Product type: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist. Official classification: Class II. Official category: Radiology. Regulation number: 892.1570. To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: OUK. Product type: Surgical Mask With Antimicrobial/Antiviral Agent. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: OUL. Product type: Thermocycler, Generic. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2310. A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run. It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats. Implant flag: N. Life-sustain/support flag: N.

Official code: OUM. Product type: Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1050. Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light. Implant flag: N. Life-sustain/support flag: N.

Official code: OUO. Product type: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance. Official classification: Class II. Official category: Radiology. Regulation number: 892.1200. Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction. Implant flag: N. Life-sustain/support flag: N.

Official code: OUP. Product type: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4790. Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite. Implant flag: N. Life-sustain/support flag: N.

Official code: OUR. Product type: Sacroiliac Joint Fixation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. sacroiliac joint fusion Implant flag: Y. Life-sustain/support flag: N.

Official code: OUS. Product type: Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2050. The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain. Implant flag: N. Life-sustain/support flag: N.

Official code: OUT. Product type: Intracranial Aneurysm Flow Diverter. Official classification: Class III. Official category: Unknown. Treatment of wide-necked and larger or giant intracranial aneurysms. Implant flag: Y. Life-sustain/support flag: N.

Official code: OUU. Product type: Polymeric Neurovascular Embolization. Official classification: HDE. Official category: Unknown. Treatment of intracranial aneurysms Implant flag: Y. Life-sustain/support flag: N.

Official code: OUW. Product type: Infant Positioner, Rx, Use In Highly Monitored Setting. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5680. Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: OUY. Product type: Trichomonas Vaginalis Nucleic Acid Amplification Test System. Official classification: Class II. Official category: Immunology. Regulation number: 866.3860. In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients Implant flag: N. Life-sustain/support flag: N.

Official code: OUZ. Product type: Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. Detection of Leishmania species in skin lesions. Implant flag: N. Life-sustain/support flag: N.

Official code: OVA. Product type: Complete Gene Expression Profiling Accessory Reagents. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes. Implant flag: N. Life-sustain/support flag: N.

Official code: OVB. Product type: Hydrogel Spacer. Official classification: Class II. Official category: Radiology. Regulation number: 892.5725. The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time. Implant flag: N. Life-sustain/support flag: N.

Official code: OVC. Product type: Headframe. Official classification: Not classified. Official category: Unknown. To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke. Implant flag: N. Life-sustain/support flag: N.

Official code: OVD. Product type: Intervertebral Fusion Device With Integrated Fixation, Lumbar. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3080. Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. Implant flag: Y. Life-sustain/support flag: N.

Official code: OVE. Product type: Intervertebral Fusion Device With Integrated Fixation, Cervical. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3080. Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. Implant flag: Y. Life-sustain/support flag: N.

Official code: OVF. Product type: Assay, Direct, Nucleic Acid Amplification, Q Fever. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3500. These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens. Implant flag: N. Life-sustain/support flag: N.

Official code: OVG. Product type: Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml). Official classification: HDE. Official category: Unknown. For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis. Implant flag: N. Life-sustain/support flag: N.

Official code: OVJ. Product type: Pulse Generator, External Pacemaker, Dual Chamber. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3600. A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction. Implant flag: N. Life-sustain/support flag: Y.

Official code: OVK. Product type: Cytokeratin Fragments 21-1 Eia Kit. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: OVL. Product type: Hemodialyzer, High Cut-Off. Official classification: HDE. Official category: Unknown. Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma. Implant flag: N. Life-sustain/support flag: N.

Official code: OVN. Product type: Suture Kit. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4830. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OVO. Product type: Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation. Official classification: Class III. Official category: Unknown. Intended as a primary joint replacement prosthesis in total hip arthroplasty. Implant flag: Y. Life-sustain/support flag: N.

Official code: OVP. Product type: Vibratory Counter-Stimulation. Official classification: Class II. Official category: Physical Medicine. Regulation number: 882.5895. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome. Implant flag: N. Life-sustain/support flag: N.

Official code: OVQ. Product type: Chronic Lymphocytic Leukemia Fish Probe Kit. Official classification: Class II. Official category: Immunology. Regulation number: 866.6040. The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information. Implant flag: N. Life-sustain/support flag: N.

Official code: OVR. Product type: Kit, First Aid, Talking. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: OVX. Product type: Water Immersion Labor Pool. Official classification: Not classified. Official category: Unknown. Partial water immersion during labor in hospitals, birth centers and home. Implant flag: N. Life-sustain/support flag: N.

Official code: OVY. Product type: Liquid Chemical Processing System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6887. The liquid chemical processing system is intended as a standard method for routine monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: OVZ. Product type: Pin, Fixation, Resorbable, Hard Tissue. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWB. Product type: Interventional Fluoroscopic X-Ray System. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. Interventional fluoroscopy Implant flag: N. Life-sustain/support flag: N.

Official code: OWD. Product type: Somatic Gene Mutation Detection System. Official classification: Class III. Official category: Unknown. The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues. Implant flag: N. Life-sustain/support flag: N.

Official code: OWE. Product type: Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement. Official classification: Class III. Official category: Unknown. Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: OWF. Product type: Immunohistochemical Assay, Helicobacter Pylori. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3110. Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use Implant flag: N. Life-sustain/support flag: N.

Official code: OWI. Product type: Bone Fixation Cerclage, Sublaminar. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3010. Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWK. Product type: Early Growth Response 1 (Egr) Fish Probe Kit. Official classification: Class II. Official category: Immunology. Regulation number: 866.6040. The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OWL. Product type: Peripheral Catheter Insertion Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: OWM. Product type: Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers. Official classification: Class II. Official category: Immunology. Regulation number: 866.6040. Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: OWN. Product type: Confocal Optical Imaging. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Collection of light signals for visualization of cellular microstructures. Implant flag: N. Life-sustain/support flag: N.

Official code: OWO. Product type: Drug-Eluting Sinus Stent. Official classification: Class III. Official category: Unknown. Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWP. Product type: Biological Sterilization Process Indicator With Recombinant-Dna Plasmid. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2805. A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. Implant flag: N. Life-sustain/support flag: N.

Official code: OWQ. Product type: Reprocessed Intravascular Ultrasound Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1200. For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology. Implant flag: N. Life-sustain/support flag: N.

Official code: OWR. Product type: Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in facial plastic surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWS. Product type: Mesh, Surgical, Collagen, Plastics, Facial Implants. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in facial plastic surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWT. Product type: Mesh, Surgical, Absorbable, Abdominal Hernia. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during hernia repair. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWU. Product type: Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWV. Product type: Mesh, Surgical, Collagen, Diaphragmatic Hernia. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWW. Product type: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during tendon repair procedures. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWX. Product type: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in tendon repair. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWY. Product type: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in tendon repair. Implant flag: Y. Life-sustain/support flag: N.

Official code: OWZ. Product type: Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during chest wall reconstruction. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXA. Product type: Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during chest wall reconstruction. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXB. Product type: Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during chest wall reconstruction. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXC. Product type: Mesh, Surgical, Absorbable, Staple Line Reinforcement. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXD. Product type: Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXE. Product type: Mesh, Surgical, Collagen, Staple Line Reinforcement. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXF. Product type: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXG. Product type: Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXH. Product type: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXI. Product type: Mesh, Surgical, Absorbable, Large Abdominal Wall Defects. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in abdominal wall defects. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXJ. Product type: Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in abdominal wall defects. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXK. Product type: Mesh, Surgical, Collagen, Large Abdominal Wall Defects. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in abdominal wall defects. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXL. Product type: Mesh, Surgical, Absorbable, Organ Support. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during organ support. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXM. Product type: Mesh, Surgical, Absorbable, Fistula. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during the repair of fistulas. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXN. Product type: Mesh, Surgical, Collagen, Fistula. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists during the repair of fistulas. Implant flag: Y. Life-sustain/support flag: N.

Official code: OXO. Product type: Image-Intensified Fluoroscopic X-Ray System, Mobile. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. Fluoroscopy of the human body. Implant flag: N. Life-sustain/support flag: N.

Official code: OXP. Product type: Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies. Implant flag: N. Life-sustain/support flag: N.

Official code: OXQ. Product type: Dressing Change Tray. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5075. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: OXR. Product type: 5-Fluorouracil Assay. Official classification: Not classified. Official category: Unknown. Measures levels of a chemotherapy drug in the blood. Implant flag: N. Life-sustain/support flag: N.

Official code: OXT. Product type: Percutaneous Surgical Set With Attachments. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4805. Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues. Implant flag: N. Life-sustain/support flag: N.

Official code: OXW. Product type: Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy. Official classification: Not classified. Official category: Unknown. Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina. Implant flag: N. Life-sustain/support flag: N.

Official code: OXZ. Product type: Pediatric/Child Facemask. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision. Implant flag: N. Life-sustain/support flag: N.

Official code: OYA. Product type: P2psa. Official classification: Class III. Official category: Unknown. Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi) Implant flag: N. Life-sustain/support flag: N.

Official code: OYB. Product type: Kit, Rna Detection, Human Papillomavirus. Official classification: Class III. Official category: Unknown. For the detection of human papillomavirus RNA to aid in assessing risk of cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: OYC. Product type: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor. Official classification: Class III. Official category: Unknown. The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor. Implant flag: N. Life-sustain/support flag: N.

Official code: OYD. Product type: Optical Diagnostic Device For Melanoma Detection. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.1820. An optical diagnostic device for melanoma detection is a prescription device that measures and analyzes optical properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma. Implant flag: N. Life-sustain/support flag: N.

Official code: OYE. Product type: Flow Cytometric Reagents And Accessories.. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: OYF. Product type: Aspiration Therapy System. Official classification: Class III. Official category: Unknown. Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults Implant flag: Y. Life-sustain/support flag: N.

Official code: OYG. Product type: St2 Assay. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1117. Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: OYH. Product type: Orthodontic Vibratory Accessory. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement. Implant flag: N. Life-sustain/support flag: N.

Official code: OYI. Product type: Non-Bronchoscopic Bronchoalveolar Lavage Catheter. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.6810. To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation. Implant flag: N. Life-sustain/support flag: N.

Official code: OYJ. Product type: Dna Specimen Collection, Saliva. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing. Implant flag: N. Life-sustain/support flag: N.

Official code: OYK. Product type: Ankle Arthroplasty Implantation System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3110. Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing. Implant flag: N. Life-sustain/support flag: N.

Official code: OYL. Product type: Tryptase Assay System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5760. An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: OYM. Product type: Prostrate Cancer Genes Nucleic Acid Amplification Test System. Official classification: Class III. Official category: Unknown. An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes. Implant flag: N. Life-sustain/support flag: N.

Official code: OYO. Product type: Culture, Intravaginal, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6165. Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period. Implant flag: N. Life-sustain/support flag: N.

Official code: OYP. Product type: Anti-Jcv Antibody Detection Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3336. The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies. Implant flag: N. Life-sustain/support flag: N.

Official code: OYR. Product type: Filler, Bone Void, Recombinant Platelet-Derived Growth Factor. Official classification: Not classified. Official category: Unknown. For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions. Implant flag: Y. Life-sustain/support flag: Y.

Official code: OYS. Product type: Patient Bed With Canopy/Restraints. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6760. Enclosed bed canopy system used as passive restraint. Implant flag: N. Life-sustain/support flag: N.

Official code: OYU. Product type: Dna-Probe Kit, Human Chromosome. Official classification: Class II. Official category: Immunology. Regulation number: 866.4700. Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen. Implant flag: N. Life-sustain/support flag: N.

Official code: OYV. Product type: Inherited Nucleotide Repeat Disorder Dna Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.5970. An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening. Implant flag: N. Life-sustain/support flag: N.

Official code: OYW. Product type: Laser, Cellulite Appearance. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. For the removal of fat through laser lipolysis. Implant flag: N. Life-sustain/support flag: N.

Official code: OYX. Product type: Bcr/Abl1 Monitoring Test. Official classification: Class II. Official category: Medical Genetics. Regulation number: 866.6060. A BCR/ABL1 Monitoring Test is a quantitative in vitro diagnostic device used to monitor the BCR/ABL1 to ABL1 ratio by reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients expressing BCR-ABL1 fusion transcripts such as e13a2 and/or e14a2. It is intended for use during monitoring of treatment response by reporting results on the international scale (%IS) and as log molecular reduction (MR) value. Implant flag: N. Life-sustain/support flag: N.

Official code: OYY. Product type: Leukemia Translocation Panel Multiplex Test. Official classification: Not classified. Official category: Unknown. The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow. It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias. Implant flag: N. Life-sustain/support flag: N.

Official code: OYZ. Product type: Group A Streptococcus Nucleic Acid Amplification Assay System. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3740. An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OZA. Product type: Test, Urea Adult And Pediatric (Breath),. Official classification: Class III. Official category: Microbiology. Regulation number: 866.3110. Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: OZB. Product type: Dengue Nucleic Acid Amplification Assay (Naat). Official classification: Class II. Official category: Microbiology. Regulation number: 866.3946. A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe). Implant flag: N. Life-sustain/support flag: N.

Official code: OZC. Product type: Over The Counter Thermal Treatment For Acne.. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5740. For the treatment of mild to moderate inflammatory acne. Implant flag: N. Life-sustain/support flag: N.

Official code: OZD. Product type: Temporary Non-Roller Type Left Heart Support Blood Pump. Official classification: Class III. Official category: Unknown. A blood pump that provides temporary full or partial left heart support Implant flag: N. Life-sustain/support flag: Y.

Official code: OZE. Product type: Influenza A And Influenza B Multiplex Nucleic Acid Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: OZF. Product type: Tissue Rna Preservative For Collection, Storage, And Transportation. Official classification: Class II. Official category: Immunology. Regulation number: 866.4070. The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing. Implant flag: N. Life-sustain/support flag: N.

Official code: OZG. Product type: Transcatheter Septal Occluder (Atrial). Official classification: Class III. Official category: Unknown. For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique. Implant flag: Y. Life-sustain/support flag: N.

Official code: OZH. Product type: Transcatheter Septal Occluder (Ventricular). Official classification: Class III. Official category: Unknown. For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique. Implant flag: Y. Life-sustain/support flag: N.

Official code: OZI. Product type: Internal Hinged Elbow Fixator. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved. Implant flag: Y. Life-sustain/support flag: N.

Official code: OZJ. Product type: Inhibitor, Postoperative Fibrosis (Adhesion Barrier). Official classification: Not classified. Official category: Unknown. The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions. Implant flag: N. Life-sustain/support flag: N.

Official code: OZK. Product type: Thermometer, Exhaled Breath. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2910. To measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients. Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma patients as an adjunct to established clinical and laboratory assessments of asthma. Implant flag: N. Life-sustain/support flag: N.

Official code: OZN. Product type: C. Difficile Toxin Gene Amplification Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3130. Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients. Implant flag: N. Life-sustain/support flag: N.

Official code: OZO. Product type: Automated Insulin Dosing , Threshold Suspend. Official classification: Class III. Official category: Unknown. An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels. Implant flag: N. Life-sustain/support flag: N.

Official code: OZP. Product type: Automated Insulin Dosing Device System, Single Hormonal Control. Official classification: Class III. Official category: Unknown. An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels. Implant flag: N. Life-sustain/support flag: N.

Official code: OZQ. Product type: Automated Insulin Dosing Device System, Bihormonal Control. Official classification: Class III. Official category: Unknown. A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels. Implant flag: N. Life-sustain/support flag: N.

Official code: OZR. Product type: Intraoral Pressure Gradient Device. Official classification: Class II. Official category: Dental. Regulation number: 872.5570. This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward. It is intended to be used while a patient is sleeping to treat obstructive sleep apnea. Implant flag: N. Life-sustain/support flag: N.

Official code: OZT. Product type: Balloon Aortic Valvuloplasty. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1255. A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve. Implant flag: N. Life-sustain/support flag: N.

Official code: OZW. Product type: Ingestible Event Marker. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6305. To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device Implant flag: N. Life-sustain/support flag: N.

Official code: OZX. Product type: Mycoplasma Pneumoniae Dna Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection. Implant flag: N. Life-sustain/support flag: N.

Official code: OZY. Product type: Chlamydophila Pneumoniae Dna Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection. Implant flag: N. Life-sustain/support flag: N.

Official code: OZZ. Product type: Bordetella Pertussis Dna Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3980. A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection. Implant flag: N. Life-sustain/support flag: N.

Official code: PAA. Product type: Automated Breast Ultrasound. Official classification: Class III. Official category: Unknown. Adjunct to mammography for breast cancer screening and diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: PAB. Product type: Cytomegalovirus (Cmv) Dna Quantitative Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3180. Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PAD. Product type: Chest Drainage Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6740. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: PAE. Product type: Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3450. Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality. Implant flag: N. Life-sustain/support flag: N.

Official code: PAF. Product type: Voltage Gated Calcium Channel (Vgcc) Antibody Assay. Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PAG. Product type: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility. Implant flag: Y. Life-sustain/support flag: N.

Official code: PAH. Product type: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility. Implant flag: Y. Life-sustain/support flag: N.

Official code: PAI. Product type: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed. Official classification: Class III. Official category: Obstetrics/Gynecology. Regulation number: 884.5980. Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally. Implant flag: Y. Life-sustain/support flag: N.

Official code: PAJ. Product type: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy. Implant flag: Y. Life-sustain/support flag: N.

Official code: PAL. Product type: Pulmonic Replacement Heart Valve. Official classification: HDE. Official category: Cardiovascular. Regulation number: 870.3925. For open surgical replacement of malfunctioning pulmonic heart valve. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PAM. Product type: Gram-Positive Bacteria And Their Resistance Markers. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3365. A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures. Implant flag: N. Life-sustain/support flag: N.

Official code: PAN. Product type: Braf Mutation Kit. Official classification: Not classified. Official category: Unknown. The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue. It is intended to aid in the treatment decisions and risk stratification of patients diagnosed with colorectal or papillary thyroid cancer. Implant flag: N. Life-sustain/support flag: N.

Official code: PAO. Product type: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3660. Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures. Implant flag: Y. Life-sustain/support flag: N.

Official code: PAP. Product type: Aortic Heart Valve, More Than Minimally Manipulated Allograft. Official classification: HDE. Official category: Unknown. Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PAQ. Product type: Test, Nr2 Antibody. Official classification: Not classified. Official category: Unknown. NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage. Implant flag: N. Life-sustain/support flag: N.

Official code: PAR. Product type: Test, Volatile Organic Compounds Breath Analysis. Official classification: HDE. Official category: Unknown. Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month. Implant flag: N. Life-sustain/support flag: N.

Official code: PAS. Product type: Rf/Microwave Hyperthermia System, Cancer Treatment. Official classification: HDE. Official category: Unknown. Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. Implant flag: N. Life-sustain/support flag: N.

Official code: PAT. Product type: Bladder System. Official classification: HDE. Official category: Unknown. for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine. Implant flag: Y. Life-sustain/support flag: N.

Official code: PAV. Product type: Catheter, Neuro-Vasculature, Occluding Balloon. Official classification: HDE. Official category: Neurology. Regulation number: 882.5150. Used to obstruct lower aortic blood flow to augment cerebral perfusion. Implant flag: N. Life-sustain/support flag: N.

Official code: PAW. Product type: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3470. To repair or replace chordae tendinae. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PAX. Product type: Surgical Kit. Official classification: HDE. Official category: Unknown. For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity. Implant flag: N. Life-sustain/support flag: N.

Official code: PAY. Product type: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4420. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use. Implant flag: N. Life-sustain/support flag: N.

Official code: PAZ. Product type: Electrical Stimulation Bladder System. Official classification: HDE. Official category: Unknown. for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation. Implant flag: Y. Life-sustain/support flag: N.

Official code: PBA. Product type: Ecarin Clotting Time. Official classification: HDE. Official category: Unknown. The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: PBC. Product type: Manual Blood Grouping And Antibody Test Systems. Official classification: Class II. Official category: Hematology. Regulation number: 864.9175. A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens. Implant flag: N. Life-sustain/support flag: N.

Official code: PBD. Product type: Composite Cultured Skin. Official classification: HDE. Official category: General, Plastic Surgery. Regulation number: 878.4024. For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB) Implant flag: Y. Life-sustain/support flag: N.

Official code: PBF. Product type: Orthopaedic Surgical Planning And Instrument Guides. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: PBH. Product type: Embryo Image Assessment System, Assisted Reproduction. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6195. The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing . Implant flag: N. Life-sustain/support flag: N.

Official code: PBI. Product type: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3310. For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered. Implant flag: Y. Life-sustain/support flag: N.

Official code: PBJ. Product type: Cranial Distraction System. Official classification: Class II. Official category: Neurology. Regulation number: 882.5330. A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PBK. Product type: Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3315. In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture. Implant flag: N. Life-sustain/support flag: N.

Official code: PBN. Product type: Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients. Official classification: HDE. Official category: Unknown. Removal of plasma components to treat focal glomerulosclerosis Implant flag: N. Life-sustain/support flag: N.

Official code: PBP. Product type: Rectal Insert. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Acts as a barrier to the passage of fecal matter through the rectum. Implant flag: N. Life-sustain/support flag: N.

Official code: PBQ. Product type: Fixation, Non-Absorbable Or Absorbable, For Pelvic Use. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. Attaching suture or stapling ligaments of the pelvic floor. Implant flag: Y. Life-sustain/support flag: N.

Official code: PBU. Product type: Bone Void Filler, Syringe. Official classification: Not classified. Official category: Unknown. To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis). Implant flag: Y. Life-sustain/support flag: N.

Official code: PBX. Product type: Massager, Vacuum, Radio Frequency Induced Heat. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite. Implant flag: N. Life-sustain/support flag: N.

Official code: PBY. Product type: Temporary Tissue Marker. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: PBZ. Product type: Image Processing Device For Estimation Of External Blood Loss. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2750. An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images. Implant flag: N. Life-sustain/support flag: N.

Official code: PCA. Product type: Dna Genetic Analyzer. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual nucleotide sequences and DNA fragment sizes are identified using chain- or dye-termination or dye primer cycle sequencing, or PCR amplification with labeled primers, respectively. Labeled nucleotides and DNA fragments are separated by size and charge using a polymer-based separation matrix with capillary electrophoresis or other method. Fluorescence emissions are measured using filters on a photodiode or other detector and interpreted with software. Implant flag: N. Life-sustain/support flag: N.

Official code: PCB. Product type: External Cerebrospinal Fluid (Csf) Diversion. Official classification: Class II. Official category: Neurology. Regulation number: 882.5560. Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion. Implant flag: N. Life-sustain/support flag: N.

Official code: PCC. Product type: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine. Official classification: Class II. Official category: Neurology. Regulation number: 882.5891. Used to apply an electrical current to a patient's cranium through electrodes placed on the skin. Implant flag: N. Life-sustain/support flag: N.

Official code: PCD. Product type: Powered Stairway Chair Lift. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5150. A powered patient stairway chair lift (Stair Machine) is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway Implant flag: N. Life-sustain/support flag: N.

Official code: PCE. Product type: Permanently Mounted Wheelchair Platform Lift. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3930. Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another. Implant flag: N. Life-sustain/support flag: N.

Official code: PCF. Product type: Sampler, Endocervical. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1050. Obtains tissue samples from the endocervical canal for histological analysis. Implant flag: N. Life-sustain/support flag: N.

Official code: PCG. Product type: 21-Hydroxylase Antibody (21-Ohab). Official classification: Class II. Official category: Immunology. Regulation number: 866.5660. For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Implant flag: N. Life-sustain/support flag: N.

Official code: PCH. Product type: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3990. A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PCI. Product type: Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3990. A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PCK. Product type: Pediatric Ventricular Assist Device. Official classification: HDE. Official category: Cardiovascular. Regulation number: 870.3545. A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PCL. Product type: Enzyme Linked Immunoabsorbent Assay, Rubeola Igm. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3520. The qualitative detection of measles specific IgM antibodies in serum or plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: PCM. Product type: Portable Liquid Oxygen Unit Stand. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position. Implant flag: N. Life-sustain/support flag: N.

Official code: PCN. Product type: Immunoglobulin G Kappa Heavy And Light Chain Combined. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Intended for the in-vitro quantification of IgG kappa concentration in human serum. Implant flag: N. Life-sustain/support flag: N.

Official code: PCO. Product type: Immunoglobulin G Lambda Heavy And Light Chain Combined. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PCQ. Product type: Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier). Official classification: Not classified. Official category: Unknown. Intended for use as a mechanical barrier to adhesion formation. Implant flag: N. Life-sustain/support flag: N.

Official code: PCS. Product type: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox. Official classification: Class II. Official category: Radiology. Regulation number: 892.1001. Intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver for any indication where an assessment of liver iron concentration is needed. For non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT patients for whom deferasirox therapy is being considered and for monitoring of NTDT patients receiving deferasirox therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: PCT. Product type: Prostate Immobilizer Rectal Balloon. Official classification: Class II. Official category: Radiology. Regulation number: 892.5720. Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: PCU. Product type: Pancreatic Stent, Covered, Metallic, Removable. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5015. To facilitate transmural endoscopic drainage of pancreatic pseudocysts Implant flag: Y. Life-sustain/support flag: N.

Official code: PCV. Product type: Endoscopic Leak Tester. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope. Implant flag: N. Life-sustain/support flag: N.

Official code: PCW. Product type: Implantable Pulse Generator, Programmer And Battery Charger. Official classification: Not classified. Official category: Unknown. intended for the treatment of moderate to severe heart failure. Implant flag: Y. Life-sustain/support flag: N.

Official code: PCX. Product type: Artificial Chordae Tendinae Delivery System. Official classification: Not classified. Official category: Unknown. Deploys ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair. Implant flag: N. Life-sustain/support flag: N.

Official code: PCY. Product type: Investigational Use Only - Microbiology. Official classification: Not classified. Official category: Unknown. Investigational use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: PCZ. Product type: Investigational Use Only - Immunology. Official classification: Not classified. Official category: Unknown. Investigational use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: PDA. Product type: Investigational Use Only - Clinical Chemistry. Official classification: Not classified. Official category: Unknown. Investigational use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: PDB. Product type: Investigational Use Only - Clinical Toxicology. Official classification: Not classified. Official category: Unknown. Investigational use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: PDC. Product type: Investigational Use Only - Hematology. Official classification: Not classified. Official category: Unknown. Investigational use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: PDD. Product type: Investigational Use Only - Pathology. Official classification: Not classified. Official category: Unknown. Investigational use only and for products imported into the US only. Implant flag: N. Life-sustain/support flag: N.

Official code: PDE. Product type: Immunoglobulin M Kappa Heavy And Light Chain Combined. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PDF. Product type: Immunoglobulin M Lambda Heavy And Light Chain Combined. Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. Intended for the in-vitro quantification of IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PDG. Product type: Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed. Implant flag: N. Life-sustain/support flag: N.

Official code: PDH. Product type: Blanket, Neonatal Phototherapy. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5700. Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. Implant flag: N. Life-sustain/support flag: N.

Official code: PDI. Product type: Beta 2-Microglobulin Apheresis Column. Official classification: HDE. Official category: Unknown. Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA). Implant flag: N. Life-sustain/support flag: N.

Official code: PDJ. Product type: Hemoglobin A1c Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1373. Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes. Implant flag: N. Life-sustain/support flag: N.

Official code: PDK. Product type: Cream For X-Ray Attenuation. Official classification: Class II. Official category: Radiology. Regulation number: 892.6510. The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: PDO. Product type: Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization. Official classification: Class II. Official category: Hematology. Regulation number: 864.1870. The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist. Implant flag: N. Life-sustain/support flag: N.

Official code: PDQ. Product type: Neurosurgical Nerve Locator. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1820. To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery. Implant flag: N. Life-sustain/support flag: N.

Official code: PDR. Product type: Computer-Assisted Personalized Sedation System. Official classification: Class III. Official category: Unknown. Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation. Implant flag: N. Life-sustain/support flag: N.

Official code: PDS. Product type: Amniotic Fluid Protein Immunoassay. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1550. To detect specified amniotic fluid proteins in cervicovaginal samples Implant flag: N. Life-sustain/support flag: N.

Official code: PDT. Product type: Burn Resuscitation Decision Support Software. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1890. The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn. Implant flag: N. Life-sustain/support flag: N.

Official code: PDU. Product type: Catheter For Crossing Total Occlusions. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement. Implant flag: N. Life-sustain/support flag: N.

Official code: PDW. Product type: Internal Tissue Marker. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4670. An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues. Implant flag: N. Life-sustain/support flag: N.

Official code: PDX. Product type: Flow Cytometry Calibrator. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers. Implant flag: N. Life-sustain/support flag: N.

Official code: PDY. Product type: Organophosphate Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3652. For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: PDZ. Product type: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.). Implant flag: N. Life-sustain/support flag: N.

Official code: PEA. Product type: Endoscope, Accessories, Image Post-Processing For Color Enhancement. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement. Implant flag: N. Life-sustain/support flag: N.

Official code: PEB. Product type: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices. Implant flag: N. Life-sustain/support flag: N.

Official code: PEC. Product type: Sterilizer Automated Loading System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6880. Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer. Implant flag: N. Life-sustain/support flag: N.

Official code: PEF. Product type: Heparin Flush In 0.45% Sodium Chloride. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling. It provides an alternative to clinicians to prevent sodium overload in neonatal patients. Implant flag: N. Life-sustain/support flag: N.

Official code: PEG. Product type: Nucleic Acid Quantitation Kit. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2310. A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence or absorbance at a specified wavelength. Implant flag: N. Life-sustain/support flag: N.

Official code: PEH. Product type: Hemodialysis Catheter Luer End Cap. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. For use in hemodialysis catheters to reduce hub infection. Implant flag: N. Life-sustain/support flag: N.

Official code: PEJ. Product type: Salivary Estriol Test. Official classification: Class III. Official category: Unknown. To detect and measure salivary estriol in pregnant women. Implant flag: N. Life-sustain/support flag: N.

Official code: PEK. Product type: Spinous Process Plate. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3050. A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use. Implant flag: Y. Life-sustain/support flag: N.

Official code: PEM. Product type: Dental Barriers And Sleeves. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients. Implant flag: N. Life-sustain/support flag: N.

Official code: PEN. Product type: Gram-Negative Bacteria And Associated Resistance Markers. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3365. A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures. Implant flag: N. Life-sustain/support flag: N.

Official code: PEO. Product type: Fungal Organisms, Nucleic Acid-Based Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3365. A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures. Implant flag: N. Life-sustain/support flag: N.

Official code: PEP. Product type: Molecular Erythrocyte Typing Test. Official classification: Class III. Official category: Unknown. Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes Implant flag: N. Life-sustain/support flag: N.

Official code: PEQ. Product type: Accessories To Examination Light. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6320. Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed. Implant flag: N. Life-sustain/support flag: N.

Official code: PER. Product type: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2750. Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis. Implant flag: N. Life-sustain/support flag: N.

Official code: PET. Product type: Anti-Ss-A Ro60 Autoantibodies. Official classification: Class II. Official category: Immunology. Regulation number: 866.5100. Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome. Implant flag: N. Life-sustain/support flag: N.

Official code: PEU. Product type: System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3373. The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PEV. Product type: Dialysis Administration Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: PEW. Product type: Implantable Transprostatic Tissue Retractor System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5530. The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above. Implant flag: Y. Life-sustain/support flag: N.

Official code: PEX. Product type: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3361. A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PEZ. Product type: Central Venous Catheter Dressing Change Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: PFA. Product type: Non-Invasive Central Venous Manometer. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1140. Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology. Implant flag: N. Life-sustain/support flag: N.

Official code: PFC. Product type: Cultured Human Cell Skin Dressing. Official classification: Class III. Official category: Unknown. Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers. Implant flag: Y. Life-sustain/support flag: N.

Official code: PFE. Product type: Gastrointestinal Liner System. Official classification: Not classified. Official category: Unknown. for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months. Implant flag: Y. Life-sustain/support flag: N.

Official code: PFF. Product type: High Throughput Dna Sequence Analyzer. Official classification: Class II. Official category: Immunology. Regulation number: 862.2265. A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample. Implant flag: N. Life-sustain/support flag: N.

Official code: PFG. Product type: Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders. Official classification: Class II. Official category: Hematology. Regulation number: 864.1870. DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PFH. Product type: Venous Window Needle Guide. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PFJ. Product type: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4260. Mechanical dilation of the cervical canal for labor. Implant flag: N. Life-sustain/support flag: N.

Official code: PFK. Product type: Quality Control For Molecular Immunohematology Tests. Official classification: Class II. Official category: Hematology. Regulation number: 864.9650. The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens. Implant flag: N. Life-sustain/support flag: N.

Official code: PFL. Product type: Intraoral, Dental Foam Protector. Official classification: Class I. Official category: Dental. Regulation number: 872.6890. Intended to provide a soft barrier between wired mouth hardware and oral mucosa. Implant flag: N. Life-sustain/support flag: N.

Official code: PFM. Product type: Hemibridge System. Official classification: Not classified. Official category: Unknown. Non-fusion growth modulation of spinal column. Implant flag: Y. Life-sustain/support flag: N.

Official code: PFN. Product type: Implanted Brain Stimulator For Epilepsy. Official classification: Class III. Official category: Unknown. For the treatment of epilepsy. Implant flag: Y. Life-sustain/support flag: N.

Official code: PFO. Product type: Active Implantable Bone Conduction Hearing System. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3340. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. Implant flag: Y. Life-sustain/support flag: N.

Official code: PFP. Product type: Silicone Hydrogel For Scar Management. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4025. Management of closed hyperproliferative (hypertrophic and keloid) scars. Implant flag: N. Life-sustain/support flag: N.

Official code: PFQ. Product type: Mmp-9 Test System. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1540. A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye. Implant flag: N. Life-sustain/support flag: N.

Official code: PFR. Product type: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection. Official classification: Class II. Official category: Immunology. Regulation number: 866.5900. The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening. Implant flag: N. Life-sustain/support flag: N.

Official code: PFS. Product type: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection. Official classification: Class II. Official category: Immunology. Regulation number: 866.5900. The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes Implant flag: N. Life-sustain/support flag: N.

Official code: PFT. Product type: Reagents For Molecular Diagnostic Test Systems. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.3800. A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems. Implant flag: N. Life-sustain/support flag: N.

Official code: PFU. Product type: Tissue Processing Kit. Official classification: Not classified. Official category: Unknown. For the preparation of human tissue specimens for frozen sectioning and histological examination. Implant flag: N. Life-sustain/support flag: N.

Official code: PFV. Product type: System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment. Official classification: Class III. Official category: Unknown. An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis. Implant flag: Y. Life-sustain/support flag: N.

Official code: PFW. Product type: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5300. Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation. Implant flag: N. Life-sustain/support flag: N.

Official code: PFX. Product type: System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection. Official classification: Class II. Official category: Immunology. Regulation number: 866.5920. A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other clinical information currently used in postnatal diagnosis. It is not intended to be used for standalone diagnostic purposes, prenatal or pre-implantation testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations. Implant flag: N. Life-sustain/support flag: N.

Official code: PFY. Product type: Low Patient Acuity Monitoring System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2300. For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients. Implant flag: N. Life-sustain/support flag: N.

Official code: PFZ. Product type: Ophthalmic Sealant. Official classification: Class III. Official category: Unknown. An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye. Implant flag: N. Life-sustain/support flag: N.

Official code: PGD. Product type: Colon Capsule Imaging System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1330. visualization of the colon for the detection of polyps Implant flag: N. Life-sustain/support flag: N.

Official code: PGE. Product type: Gastric Emptying Breath Test. Official classification: Class III. Official category: Unknown. Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal. Implant flag: N. Life-sustain/support flag: N.

Official code: PGH. Product type: Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3307. Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Implant flag: N. Life-sustain/support flag: Y.

Official code: PGI. Product type: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3309. For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid. Implant flag: N. Life-sustain/support flag: N.

Official code: PGJ. Product type: Oximeter, Wellness. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Pulse oximeter intended for wellness use. Implant flag: N. Life-sustain/support flag: N.

Official code: PGK. Product type: Cannula, Injector, Uterine, Endometrial Biopsy. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy Implant flag: N. Life-sustain/support flag: N.

Official code: PGM. Product type: Growing Rod System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. Stabilization or correction of spinal deformities without the use of fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: PGN. Product type: Growing Rod System- Magnetic Actuation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod. Implant flag: Y. Life-sustain/support flag: N.

Official code: PGO. Product type: Anti-Stick Glass Syringe. Official classification: Not classified. Official category: Unknown. Single use devices that are indicated for use as an accessory with sterile 1ML long staked needle prefilled ISO standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject, doctor prescribed medications, and individuals that assist self-injecting patients from accidental needle sticks. Can be used on a wide range of patients including children and adults. Implant flag: N. Life-sustain/support flag: N.

Official code: PGQ. Product type: Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification. Official classification: Class III. Official category: Unknown. Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity. Implant flag: Y. Life-sustain/support flag: N.

Official code: PGT. Product type: Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1710. to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: PGU. Product type: Spatial Imaging For Display Of Endoscope Position. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To detect and display the shape of an inserted endoscope. Implant flag: N. Life-sustain/support flag: N.

Official code: PGV. Product type: Anti-Phospholipase A2 Receptor. Official classification: Class II. Official category: Microbiology. Regulation number: 866.5780. The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings. Implant flag: N. Life-sustain/support flag: Y.

Official code: PGW. Product type: Ear, Nose, And Throat Stereotaxic Instrument. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy. Implant flag: N. Life-sustain/support flag: N.

Official code: PGX. Product type: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2680. An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients. Implant flag: N. Life-sustain/support flag: N.

Official code: PGY. Product type: Display, Diagnostic Radiology. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. Implant flag: N. Life-sustain/support flag: N.

Official code: PGZ. Product type: Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4452. To control bleeding in junctional, non-compressible wounds until surgical care is acquired. Implant flag: N. Life-sustain/support flag: N.

Official code: PHC. Product type: Infusion Safety Management Software. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission. Implant flag: N. Life-sustain/support flag: N.

Official code: PHF. Product type: Zinc Transporter 8 Auto-Antibody. Official classification: Class II. Official category: Immunology. Regulation number: 866.5670. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PHG. Product type: Droplet Digital Pcr System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique. A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays which specify its use. Implant flag: N. Life-sustain/support flag: N.

Official code: PHJ. Product type: System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations. Official classification: Class II. Official category: Hematology. Regulation number: 864.7280. A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia. Implant flag: N. Life-sustain/support flag: N.

Official code: PHK. Product type: Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation. Official classification: Not classified. Official category: Unknown. The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information. Implant flag: N. Life-sustain/support flag: N.

Official code: PHL. Product type: Powered Exoskeleton. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3480. A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: PHM. Product type: Intervertebral Fusion Device With Bone Graft, Thoracic. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3080. Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. Implant flag: Y. Life-sustain/support flag: N.

Official code: PHN. Product type: Protective Coating, Mucoadhesive Application, For The Rectal Mucosa. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Mucoadhesive application for the protective coating of the rectal mucosa. Implant flag: N. Life-sustain/support flag: N.

Official code: PHO. Product type: Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs. Official classification: Class III. Official category: Unknown. Preservation of donor lungs for transplantation. Implant flag: N. Life-sustain/support flag: Y.

Official code: PHP. Product type: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection. Official classification: Class III. Official category: Unknown. The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. Implant flag: N. Life-sustain/support flag: N.

Official code: PHQ. Product type: Anterior Staple As Supplemental Fixation For Fusion. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Anterior cervical device for supplemental fixation to support a fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: PHR. Product type: Diammine Silver Fluoride Dental Hypersensitivity Varnish. Official classification: Class II. Official category: Dental. Regulation number: 872.3260. Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity. Implant flag: N. Life-sustain/support flag: N.

Official code: PHS. Product type: Oral Airway Assist. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.5110. To assist in maintaining an open airway. Implant flag: N. Life-sustain/support flag: N.

Official code: PHT. Product type: Basin For Endoscope Reprocessing. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To allow endoscopes to soak in reprocessing solutions. Implant flag: N. Life-sustain/support flag: N.

Official code: PHU. Product type: Intra-Abdominal Pressure Monitoring Device. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure. Implant flag: Y. Life-sustain/support flag: N.

Official code: PHV. Product type: Continuous Glucose Monitor Retrospective Data Analysis Software. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2120. Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device. Implant flag: N. Life-sustain/support flag: N.

Official code: PHW. Product type: Cold Pack And Vibrating Massager. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5975. Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture). Implant flag: N. Life-sustain/support flag: N.

Official code: PHX. Product type: Shoulder Prosthesis, Reverse Configuration. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3660. Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint. Implant flag: Y. Life-sustain/support flag: N.

Official code: PHY. Product type: Sparse Sample Pk Profile And Dosing Software. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1890. To estimate PK profile and dosing calculation. Implant flag: N. Life-sustain/support flag: N.

Official code: PHZ. Product type: Abnormal Breath Sound Device. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1900. The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling. Implant flag: N. Life-sustain/support flag: N.

Official code: PIA. Product type: Vibrator For Climax Control Of Premature Ejaculation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5025. Vibrator for climax control training for the treatment of premature ejaculation. Implant flag: N. Life-sustain/support flag: N.

Official code: PIB. Product type: Diabetic Retinopathy Detection Device. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1100. A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: PIC. Product type: Oral Electronic Vision Aid. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5905. To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.) Implant flag: N. Life-sustain/support flag: N.

Official code: PID. Product type: Esophageal Dilator Balloon With Or Without Electrode Sensors. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. To dilate the lower esophageal sphincter of patients with Achalasia. Implant flag: N. Life-sustain/support flag: N.

Official code: PIE. Product type: Esophageal Dilator With Balloon And Electrode Sensors. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. To dilate esophageal strictures with a dilating balloon and electrode sensors. Implant flag: N. Life-sustain/support flag: N.

Official code: PIF. Product type: Gastrointestinal Tubes With Enteral Specific Connectors. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. To facilitate enteral specific connections. Implant flag: N. Life-sustain/support flag: N.

Official code: PIG. Product type: Acute Kidney Injury Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1220. An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods. Implant flag: N. Life-sustain/support flag: N.

Official code: PIH. Product type: Urethral Insert With Pump For Bladder Drainage. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5140. The device is intended to empty urine from the bladder under patient control. Implant flag: Y. Life-sustain/support flag: N.

Official code: PII. Product type: Candida Species Nucleic Acid Detection System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3960. The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification. Implant flag: N. Life-sustain/support flag: N.

Official code: PIJ. Product type: Collagen Surgical Mesh Containing Drugs. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. Reinforcement of soft tissue where weakness exists. Implant flag: Y. Life-sustain/support flag: N.

Official code: PIK. Product type: Metabolic Neuromodulation System. Official classification: Not classified. Official category: Unknown. The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves surrounding the common hepatic artery. Implant flag: N. Life-sustain/support flag: N.

Official code: PIL. Product type: Test For Periprosthetic Joint Infection. Official classification: Not classified. Official category: Unknown. A qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint. Implant flag: N. Life-sustain/support flag: N.

Official code: PIM. Product type: Neuromodulator For Obesity. Official classification: Class III. Official category: Unknown. Weight reduction by peripheral neuromodulation. Implant flag: Y. Life-sustain/support flag: N.

Official code: PIN. Product type: Kidney Perfusion Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5880. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: PIO. Product type: Enteral Specific Transition Connectors. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors. Implant flag: N. Life-sustain/support flag: N.

Official code: PIP. Product type: Prophy Powder, Airbrush Accessory. Official classification: Class II. Official category: Dental. Regulation number: 872.6080. An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity. Implant flag: N. Life-sustain/support flag: N.

Official code: PIQ. Product type: Reagents For Detection Of Norovirus Nucleic Acid. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3990. Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis. Implant flag: N. Life-sustain/support flag: N.

Official code: PIR. Product type: Mercy Tape 2d And 3d Models. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC). Implant flag: N. Life-sustain/support flag: N.

Official code: PIT. Product type: Leishmania Spp. Antigen Detection Assay. Official classification: Class I. Official category: Microbiology. Regulation number: 866.3870. An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection. Implant flag: N. Life-sustain/support flag: N.

Official code: PIV. Product type: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use. Official classification: Class II. Official category: Immunology. Regulation number: 866.4750. Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results. Implant flag: N. Life-sustain/support flag: N.

Official code: PIW. Product type: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.1450. A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: PIX. Product type: Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis. Official classification: Not classified. Official category: Unknown. An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint. Implant flag: Y. Life-sustain/support flag: N.

Official code: PIY. Product type: Stainless Steel Instrument, Shunt System Implantation. Official classification: Class I. Official category: Neurology. Regulation number: 882.4545. A stainless steel shunt system implantation instrument is an instrument made entirely of stainless steel used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin. Implant flag: N. Life-sustain/support flag: N.

Official code: PIZ. Product type: Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve. Official classification: Class III. Official category: Unknown. Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. Implant flag: N. Life-sustain/support flag: Y.

Official code: PJA. Product type: Coronary Vascular Physiologic Simulation Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1415. A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. Implant flag: N. Life-sustain/support flag: N.

Official code: PJB. Product type: Catheter Remote Control System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5700. A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: PJC. Product type: Newborn Screening Specimen Collection Paper. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis. Implant flag: N. Life-sustain/support flag: N.

Official code: PJD. Product type: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing. Implant flag: N. Life-sustain/support flag: N.

Official code: PJE. Product type: Blood/Plasma Collection Device For Dna Testing. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing. Implant flag: N. Life-sustain/support flag: N.

Official code: PJF. Product type: Illuminator System For Blood Products. Official classification: Class III. Official category: Unknown. Preparation and storage of pathogen-reduced, blood components. Implant flag: N. Life-sustain/support flag: N.

Official code: PJG. Product type: Cancer-Related Germline Gene Mutation Detection System. Official classification: Class III. Official category: Unknown. The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PJH. Product type: Dynamic Rectal Control System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5930. Intended to treat fecal incontinence by controlling the size of the rectal lumen. Implant flag: N. Life-sustain/support flag: N.

Official code: PJI. Product type: Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5930. A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID). Implant flag: N. Life-sustain/support flag: N.

Official code: PJJ. Product type: Two Or More Sterilant Sterilizer. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6860. Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities. Implant flag: N. Life-sustain/support flag: N.

Official code: PJK. Product type: Tissue Adhesive For Internal Use. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4010. Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty. Implant flag: Y. Life-sustain/support flag: N.

Official code: PJM. Product type: Filler, Bone Void, Alterable Compound For Cranioplasty. Official classification: Class II. Official category: Neurology. Regulation number: 882.5320. An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material. Implant flag: Y. Life-sustain/support flag: N.

Official code: PJN. Product type: Filler, Bone Void, Non-Alterable Compound For Cranioplasty. Official classification: Class II. Official category: Neurology. Regulation number: 882.5330. A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material. Implant flag: Y. Life-sustain/support flag: N.

Official code: PJO. Product type: Fall Prevention Alarm/Sensor Combination Attached Or Unattached. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2400. The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it. Implant flag: N. Life-sustain/support flag: N.

Official code: PJP. Product type: Fall Prevention Alarm/Sensor Attached Only. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2400. This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt . Implant flag: N. Life-sustain/support flag: N.

Official code: PJQ. Product type: Agent, Occluding, Vascular, Permanent. Official classification: Class III. Official category: Unknown. The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels. Implant flag: Y. Life-sustain/support flag: N.

Official code: PJS. Product type: Stimulator, Electrical, Implanted, For Essential Tremor. Official classification: Class III. Official category: Unknown. Deep Brain Stimulation for the treatment of essential tremor Implant flag: Y. Life-sustain/support flag: N.

Official code: PJT. Product type: Continuous Glucose Monitor Secondary Display. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1350. The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring Implant flag: N. Life-sustain/support flag: N.

Official code: PJY. Product type: Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees. Official classification: Class III. Official category: Unknown. The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb. Implant flag: Y. Life-sustain/support flag: N.

Official code: PJZ. Product type: Camera, Ophthalmic, General-Use. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1120. PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments. Implant flag: N. Life-sustain/support flag: N.

Official code: PKA. Product type: External Upper Esophageal Sphincter (Ues) Compression Device. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.5900. The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. Implant flag: N. Life-sustain/support flag: N.

Official code: PKB. Product type: Autosomal Recessive Carrier Screening Gene Mutation Detection System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5940. Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing. Implant flag: N. Life-sustain/support flag: N.

Official code: PKC. Product type: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3660. Replacement of the humeral head for total anatomic shoulder arthroplasty Implant flag: Y. Life-sustain/support flag: N.

Official code: PKD. Product type: Laceration Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PKE. Product type: Laparoscopic Cholecystectomy Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PKF. Product type: D And C Tray. Official classification: Not classified. Official category: Unknown. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: PKG. Product type: Bone Marrow Processing Device To Support Hematopoietic Reconstitution. Official classification: Class II. Official category: Hematology. Regulation number: 864.9245. Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient. Implant flag: N. Life-sustain/support flag: N.

Official code: PKI. Product type: Fully Subcutaneous Implanted Hemodialysis Catheter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. Provides access to the blood for hemodialysis or other chronic uses. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PKJ. Product type: Crown And Bridge Material, Resin Based. Official classification: Not classified. Official category: Unknown. Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications. Implant flag: N. Life-sustain/support flag: N.

Official code: PKK. Product type: Stent Delivery System. Official classification: Not classified. Official category: Unknown. For coarctation of the aorta Implant flag: Y. Life-sustain/support flag: N.

Official code: PKL. Product type: Hemostatic Metal Clip For The Gi Tract. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4400. Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PKM. Product type: Chemiluminescent Immunoassay System. Official classification: Not classified. Official category: Unknown. For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum. Implant flag: N. Life-sustain/support flag: N.

Official code: PKN. Product type: Dilator, Cervical, Synthetic, Osmotic. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4260. Cervical softening and dilation Implant flag: N. Life-sustain/support flag: N.

Official code: PKO. Product type: Transparent Patch For Use In Treatment Of Tattoos. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. To reduce formation of bubbles during laser treatment of tattoos. Implant flag: N. Life-sustain/support flag: N.

Official code: PKP. Product type: Immunoglobulin G (Igg) Infusion System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling. Implant flag: N. Life-sustain/support flag: N.

Official code: PKQ. Product type: Computerized Cognitive Assessment Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.1470. The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time Implant flag: N. Life-sustain/support flag: N.

Official code: PKR. Product type: Non-Invasive Vagus Nerve Stimulator - Headache. Official classification: Class II. Official category: Neurology. Regulation number: 882.5892. The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks. Implant flag: N. Life-sustain/support flag: N.

Official code: PKS. Product type: Exerciser, Non-Measuring For Stroke Rehabilitation. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5370. Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion. Implant flag: N. Life-sustain/support flag: N.

Official code: PKT. Product type: Laser For Disruption Of Adipocyte Cells For Aesthetic Use. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5400. Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas. Implant flag: N. Life-sustain/support flag: N.

Official code: PKU. Product type: Insulin Pump Secondary Display. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1350. The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: PKW. Product type: Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase. Official classification: Class III. Official category: Unknown. The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: PKY. Product type: Implant, Dermal, For Aesthetic Use In The Hands. Official classification: Class III. Official category: Unknown. For hand augmentation to correct volume loss in the dorsum of the hands. Implant flag: Y. Life-sustain/support flag: N.

Official code: PLA. Product type: Esophageal Thermal Regulation And Gastric Suctioning Device. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5910. The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage. Implant flag: N. Life-sustain/support flag: N.

Official code: PLB. Product type: Multivariate Vital Signs Index. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2300. Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs. Implant flag: N. Life-sustain/support flag: N.

Official code: PLC. Product type: Sleep Appliances With Patient Monitoring. Official classification: Class II. Official category: Dental. Regulation number: 872.5570. For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: PLF. Product type: Bone Wedge. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3030. Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia. Implant flag: Y. Life-sustain/support flag: N.

Official code: PLH. Product type: Orthodontic Led Accessory. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement. Implant flag: N. Life-sustain/support flag: N.

Official code: PLI. Product type: Gastrointestional Tube Holder. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Intended to support, secure, and hold gastrointestinal tubes Implant flag: N. Life-sustain/support flag: N.

Official code: PLJ. Product type: Tissue Adhesive Internal Use. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4010. Intended for the fixation of surgical meshes. Implant flag: Y. Life-sustain/support flag: N.

Official code: PLK. Product type: Tympanic Membrane Direct Contact Hearing Aid. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3315. A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. Implant flag: Y. Life-sustain/support flag: N.

Official code: PLL. Product type: Submucosal Injection Agent. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Implant flag: N. Life-sustain/support flag: N.

Official code: PLO. Product type: Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3970. A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PLP. Product type: High Intensity Ultrasound System For Prostate Tissue Ablation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4340. Prostate tissue ablation Implant flag: N. Life-sustain/support flag: N.

Official code: PLQ. Product type: Enzyme Packed Cartridge. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5985. Hydrolyze fats in enteral formula. Implant flag: N. Life-sustain/support flag: N.

Official code: PLR. Product type: Spinal Vertebral Body Replacement Device - Cervical. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3060. Vertebral body replacement in the cervical spine. Implant flag: Y. Life-sustain/support flag: N.

Official code: PLS. Product type: Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1. Official classification: Class III. Official category: Unknown. The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: PLU. Product type: Thermal System For Insomnia. Official classification: Class II. Official category: Neurology. Regulation number: 882.5700. A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface. Implant flag: N. Life-sustain/support flag: N.

Official code: PLV. Product type: Dental Stereotaxic Instrument. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. To facilitate dental implant placement in patients that are partially endentulous or edentulous. Implant flag: N. Life-sustain/support flag: N.

Official code: PLW. Product type: Acetabular Cup Orientation System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3350. The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans. Implant flag: N. Life-sustain/support flag: N.

Official code: PLX. Product type: Tear Duct Occluder. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.5838. A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the duct. Implant flag: N. Life-sustain/support flag: N.

Official code: PLY. Product type: Antimicrobial Drapes. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: PLZ. Product type: Ocular Pattern Recorder. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1925. A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation. Implant flag: N. Life-sustain/support flag: N.

Official code: PMB. Product type: External Airway. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5105. This device is intended to maintain airway patency using negative pressure during mild to moderate sedation. Implant flag: N. Life-sustain/support flag: N.

Official code: PMC. Product type: Scalp Cooling System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4360. A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used. Implant flag: N. Life-sustain/support flag: N.

Official code: PME. Product type: External Cleaning Solution. Official classification: Class II. Official category: Dental. Regulation number: 872.3260. For use on dental restorations, external to the mouth, prior to insertion into the mouth. Implant flag: N. Life-sustain/support flag: N.

Official code: PMG. Product type: Automated Multicolor Fluorescent Imaging Cytometric Analysis System. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements. Implant flag: N. Life-sustain/support flag: N.

Official code: PMH. Product type: Mechanical Compression Device Fecal Incontinence (Non-Manually Operated). Official classification: HDE. Official category: Unknown. For treatment of fecal incontinence in patients who have failed conservative therapies Implant flag: Y. Life-sustain/support flag: N.

Official code: PMI. Product type: Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement. Official classification: Class III. Official category: Unknown. A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate. Implant flag: N. Life-sustain/support flag: N.

Official code: PMJ. Product type: Cpr Aid Feedback Device (No Software). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5210. Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines Implant flag: N. Life-sustain/support flag: N.

Official code: PMK. Product type: Cpr Aid Device Without Feedback. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.5210. A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim. Implant flag: N. Life-sustain/support flag: N.

Official code: PML. Product type: Bone Cement, Posterior Screw Augmentation. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3027. The device is intended to augment the fixation of screws in a posterior spinal system construct. Implant flag: Y. Life-sustain/support flag: N.

Official code: PMN. Product type: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3920. Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use. Implant flag: N. Life-sustain/support flag: N.

Official code: PMP. Product type: Dorsal Root Ganglion Stimulator For Pain Relief. Official classification: Class III. Official category: Unknown. Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs. Implant flag: Y. Life-sustain/support flag: N.

Official code: PMQ. Product type: Peripheral Blood Processing Device For Wound Management. Official classification: Class II. Official category: Hematology. Regulation number: 864.9245. Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management. Implant flag: N. Life-sustain/support flag: N.

Official code: PMS. Product type: Peripheral Intravenous (Piv) Infiltration Monitor. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations. Implant flag: N. Life-sustain/support flag: N.

Official code: PMT. Product type: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock. Implant flag: N. Life-sustain/support flag: N.

Official code: PMU. Product type: Containment System, Laparoscopic Power Morcellation, With Instrument Port. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4050. Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation. Implant flag: N. Life-sustain/support flag: N.

Official code: PMV. Product type: Orthosis, Limb, For Back Pain. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities. Implant flag: N. Life-sustain/support flag: N.

Official code: PMW. Product type: Strabismus Detection Device. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1342. For the automated detection of misalignment of the visual axes for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: PMX. Product type: Absorbable Collagen Hemostatic Agent With Thrombin. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4490. Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Implant flag: Y. Life-sustain/support flag: N.

Official code: PMY. Product type: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology. Implant flag: N. Life-sustain/support flag: N.

Official code: PNA. Product type: Evoked Photon Image Capture Device. Official classification: Class I. Official category: Neurology. Regulation number: 882.1561. The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin. Implant flag: N. Life-sustain/support flag: N.

Official code: PNB. Product type: Biliary Stent System For Benign Strictures. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5011. A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts. Implant flag: Y. Life-sustain/support flag: N.

Official code: PNC. Product type: Catheter Introducer. Official classification: Not classified. Official category: Unknown. The catheter introducer is intended to provide a path for a catheter to be placed near nerves or into and around wound sites for the delivery local anesthesia. Implant flag: N. Life-sustain/support flag: N.

Official code: PND. Product type: Midline Catheter. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days. Implant flag: N. Life-sustain/support flag: N.

Official code: PNE. Product type: Reprocessed Catheter Introducer. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1340. Introduce various cardiovascular catheters into the heart and cardiovascular system Implant flag: N. Life-sustain/support flag: N.

Official code: PNF. Product type: Aortic Stent. Official classification: Class III. Official category: Unknown. Coarctation of the Aorta Implant flag: Y. Life-sustain/support flag: Y.

Official code: PNG. Product type: Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. For drainage of refractory ascites with long-term occurrence from the peritoneal cavity. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PNI. Product type: Aquaporin-4 Autoantibody. Official classification: Class II. Official category: Immunology. Regulation number: 866.5665. For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PNJ. Product type: Leadless Pacemaker. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.3610. To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PNK. Product type: Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53). Official classification: Class III. Official category: Unknown. A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL). Implant flag: N. Life-sustain/support flag: N.

Official code: PNL. Product type: Magnetic Surgical System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4815. System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: PNN. Product type: Orthodontic Software. Official classification: Class II. Official category: Dental. Regulation number: 872.5470. The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: PNO. Product type: Catheter, Percutaneous, Cutting/Scoring. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material Implant flag: N. Life-sustain/support flag: N.

Official code: PNP. Product type: Dental Abutment Design Software For Dental Laboratory. Official classification: Class II. Official category: Dental. Regulation number: 872.3630. The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment. Implant flag: Y. Life-sustain/support flag: N.

Official code: PNQ. Product type: Apical Closure Device. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4510. This device is intended for closure of cardiac apical tissue. Implant flag: Y. Life-sustain/support flag: N.

Official code: PNR. Product type: Enteral Syringes With Enteral Specific Connectors. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors. Implant flag: N. Life-sustain/support flag: N.

Official code: PNS. Product type: Short-Term Intravascular Filter Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3375. For short-term prevention of pulmonary embolism (PE) Implant flag: Y. Life-sustain/support flag: N.

Official code: PNU. Product type: Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5210. Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery Implant flag: N. Life-sustain/support flag: N.

Official code: PNV. Product type: Impedance Measuring Device Utilizing Oscillation Techniques. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1840. This device measures respiratory impedance. Implant flag: N. Life-sustain/support flag: N.

Official code: PNW. Product type: Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant. Official classification: Class III. Official category: Unknown. The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint. Implant flag: Y. Life-sustain/support flag: N.

Official code: PNY. Product type: Absorbable Coronary Drug-Eluting Stent. Official classification: Class III. Official category: Unknown. An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PNZ. Product type: Eustachian Tube Balloon Dilation Device. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4180. The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction. Implant flag: N. Life-sustain/support flag: N.

Official code: POA. Product type: Reagents, Zika Virus Nucleic Acid. Official classification: Not classified. Official category: Unknown. Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: POC. Product type: System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology. Implant flag: N. Life-sustain/support flag: N.

Official code: POD. Product type: Temporary, Internal Use Hemostatic. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4454. Intended to control severely bleeding wounds Implant flag: N. Life-sustain/support flag: Y.

Official code: POE. Product type: Extended Depth Of Focus Intraocular Lens. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. Intended to be implanted to replace the natural lens of an eye. Implant flag: Y. Life-sustain/support flag: N.

Official code: POG. Product type: Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid. Official classification: Not classified. Official category: Unknown. Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens Implant flag: N. Life-sustain/support flag: N.

Official code: POH. Product type: Mr-Guided Focused Ultrasound System. Official classification: Class III. Official category: Unknown. An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure. Implant flag: N. Life-sustain/support flag: N.

Official code: POI. Product type: Lung Tissue Sealant For Lung Volume Reduction. Official classification: Not classified. Official category: Unknown. The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both small airways and collateral air channels through sealing lung tissue, causing the treated area to collapse via absorption atelectasis. It is a single use device intended to be used by pulmonologists and thoracic surgeons in a bronchoscopy suite or operating room. Implant flag: Y. Life-sustain/support flag: N.

Official code: POK. Product type: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Official classification: Class II. Official category: Radiology. Regulation number: 892.2060. Assist users in characterizing lesions identified on acquired medical images Implant flag: N. Life-sustain/support flag: N.

Official code: POL. Product type: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment. Official classification: Class II. Official category: Neurology. Regulation number: 882.5600. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. Implant flag: N. Life-sustain/support flag: N.

Official code: POM. Product type: Computerized Cognitive Assessment Aid For Concussion. Official classification: Class II. Official category: Neurology. Regulation number: 882.1471. For use as an assessment aid in the management of concussion. Implant flag: N. Life-sustain/support flag: N.

Official code: PON. Product type: Catheter, Balloon, Dilation Of Cervical Canal. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4260. Mechanical dilation and softening of the cervix. Implant flag: N. Life-sustain/support flag: N.

Official code: POP. Product type: Cranial Motion Measurement Device. Official classification: Class II. Official category: Neurology. Regulation number: 882.1630. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: POQ. Product type: Blood Transfusion Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: POR. Product type: Parenteral Administration Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. Implant flag: N. Life-sustain/support flag: N.

Official code: POS. Product type: Physiological Signal Based Seizure Monitoring System. Official classification: Class II. Official category: Neurology. Regulation number: 882.1580. The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device. Implant flag: N. Life-sustain/support flag: N.

Official code: POT. Product type: Lockbox (Export Only). Official classification: Not classified. Official category: Unknown. The lockbox is intended to hold an infusion pump and keep the medication syringe contained within the pump relatively secure. Implant flag: N. Life-sustain/support flag: N.

Official code: POV. Product type: Semen Analysis Device. Official classification: Class II. Official category: Hematology. Regulation number: 864.5220. Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH. Implant flag: N. Life-sustain/support flag: N.

Official code: POW. Product type: Crown And Bridge, Long-Term Temporary, Resin. Official classification: Class II. Official category: Dental. Regulation number: 872.3770. For the fabrication of long-term temporary crowns and bridges Implant flag: N. Life-sustain/support flag: N.

Official code: POX. Product type: Enzyme Immunoassay, Oxcarbazepine Metabolite. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3645. An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: POY. Product type: Post Breast Biopsy Hemostatic Breast Compression Device. Official classification: Class II. Official category: Radiology. Regulation number: 892.1710. To achieve and maintain hemostasis of a breast biopsy wound site. Implant flag: N. Life-sustain/support flag: N.

Official code: POZ. Product type: Biopsy Needle Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPA. Product type: Bladder Irrigation Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPB. Product type: Foley Catheter Kit (Excludes Hiv Testing). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPC. Product type: Male External Catheterization Kit (Excludes Hiv Testing). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPD. Product type: Universal Drainage Tray. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPE. Product type: Nephroscope Set. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPF. Product type: Urinary Irrigation Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPG. Product type: Urinary Drainage Collection Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPH. Product type: Single Needle With Uni-Directional Pump Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPI. Product type: Hemodialysis Tray (Not A Start/Stop Kit). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPJ. Product type: Peritoneal Dialysis Administration Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPK. Product type: Peritoneal Dialysis Tubing Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPL. Product type: Single Needle (Co-Axial Flow) Dialysis Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPM. Product type: General Purpose Reagent. Official classification: Class I. Official category: Pathology. Regulation number: 864.4010. A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. Implant flag: N. Life-sustain/support flag: N.

Official code: PPN. Product type: Percutaneous Catheter, Ultrasound. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature. Implant flag: N. Life-sustain/support flag: N.

Official code: PPO. Product type: Multi-Lumen Hemodialysis Catheterization Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5540. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPP. Product type: Disposable Joint Aspiration/Injection Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.Pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPQ. Product type: Transtibial Anterior Cruciate Ligament Kit. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPR. Product type: Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1100. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PPS. Product type: Sleeve, Head And Neck, Compressible. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5800. Intended to move excess fluid from the target area to another area of the body. Implant flag: N. Life-sustain/support flag: N.

Official code: PPT. Product type: Cranial Surgical Planning And Instrument Guides. Official classification: Class II. Official category: Neurology. Regulation number: 882.4310. Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: PPU. Product type: Microbial Colony Image Assessment System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2190. A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist. Implant flag: N. Life-sustain/support flag: N.

Official code: PPW. Product type: Adjunctive Cardiovascular Status Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2200. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: PQA. Product type: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3975. A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections. Implant flag: N. Life-sustain/support flag: N.

Official code: PQC. Product type: Pedicle Screw Placement Guide. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans. Implant flag: N. Life-sustain/support flag: N.

Official code: PQD. Product type: Blood Specimen Collection Convenience Kit (Excludes Hiv). Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PQE. Product type: Ostomy Care Kit. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5900. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PQF. Product type: Sensor, Glucose, Invasive, Non-Adjunctive. Official classification: Class III. Official category: Unknown. A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments. Implant flag: N. Life-sustain/support flag: N.

Official code: PQH. Product type: Iodinated Contrast Media Transfer Tubing Set. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple sterile single use syringes from an imaging bulk package contrast media bulk package under controlled ambient filling conditions such as a CT suite. Implant flag: N. Life-sustain/support flag: N.

Official code: PQI. Product type: Wound Retraction And Protection System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4371. A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound. Implant flag: N. Life-sustain/support flag: N.

Official code: PQJ. Product type: Intranasal Electrostimulation Device. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5300. This device type is intended to temporarily increase tear production using neurostimulation in adult patients. Implant flag: N. Life-sustain/support flag: N.

Official code: PQK. Product type: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1252. Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis. Implant flag: N. Life-sustain/support flag: N.

Official code: PQM. Product type: Surgical Smoke Precipitator. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5050. The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools. Implant flag: N. Life-sustain/support flag: N.

Official code: PQN. Product type: Carbon Dioxide Gas Controlled Tissue Expander. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3510. A carbon dioxide gas controlled tissue expander is intended for tissue expansion. Implant flag: Y. Life-sustain/support flag: N.

Official code: PQO. Product type: Anti-Müllerian Hormone Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1092. An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women. Implant flag: N. Life-sustain/support flag: N.

Official code: PQP. Product type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System. Official classification: Class III. Official category: Unknown. A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PQQ. Product type: Data Acquisition Software. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.2570. Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments. Implant flag: N. Life-sustain/support flag: N.

Official code: PQT. Product type: Alpha-L-Iduronidase (Idua) Newborn Screening Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1488. Intended for quantitative measurement of the activity of alpha-L-iduronidase (IDUA) from newborn dried blood spot specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PQU. Product type: Alpha-D-Glucosidase (Gaa) Newborn Screening Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1488. For quantitative measurement of the activity of alpha-D-glucosidase (GAA) from newborn dried blood spot specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PQV. Product type: ß-Glucocerebrosidase (Gba) Newborn Screening Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1488. For quantitative measurement of the activity of ß-glucocerebrosidase (GBA) from newborn dried blood spot specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PQW. Product type: Alpha-D-Galactosidase A (Gla) Newborn Screening Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1488. For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: PQX. Product type: Epinephrine Syringe. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. Intended for intramuscular or subcutaneous injection of epinephrine. Implant flag: N. Life-sustain/support flag: N.

Official code: PQY. Product type: Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5290. Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain. Implant flag: N. Life-sustain/support flag: N.

Official code: PQZ. Product type: Gbs Culture Media, Selective And Differential. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2360. Culture Medium for GBS Detection Implant flag: N. Life-sustain/support flag: N.

Official code: PRA. Product type: Variola Virus Nucleic Acid-Based Detection Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3316. The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government. Implant flag: N. Life-sustain/support flag: N.

Official code: PRB. Product type: Cervical Intraepithelial Neoplasia (Cin) Test System. Official classification: Class II. Official category: Pathology. Regulation number: 864.1865. The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information. Implant flag: N. Life-sustain/support flag: N.

Official code: PRC. Product type: Drug-Coated Peripheral Transluminal Angioplasty Catheter. Official classification: Class III. Official category: Unknown. Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency Implant flag: N. Life-sustain/support flag: N.

Official code: PRE. Product type: Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood. Implant flag: N. Life-sustain/support flag: N.

Official code: PRF. Product type: Docetaxel / Paclitaxel Assay. Official classification: Not classified. Official category: Unknown. Measures levels of Docetaxel or Paclitaxel in the blood Implant flag: N. Life-sustain/support flag: N.

Official code: PRH. Product type: Positive Blood Culture Identification And Ast Kit. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1650. Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets. Implant flag: N. Life-sustain/support flag: N.

Official code: PRI. Product type: Procalcitonin Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). Implant flag: N. Life-sustain/support flag: N.

Official code: PRJ. Product type: Capillary Blood Collection Device For Alternative Site Collection. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes. Implant flag: N. Life-sustain/support flag: N.

Official code: PRK. Product type: Device Indicating An Exhalation Event. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2375. To provide visual indication of each exhalation event Implant flag: N. Life-sustain/support flag: N.

Official code: PRL. Product type: Iliac Covered Stent, Arterial. Official classification: Class III. Official category: Unknown. For the treatment of de novo or restenotic lesions found in iliac arteries Implant flag: Y. Life-sustain/support flag: N.

Official code: PRM. Product type: Enteral Administration Kit (Adult & Pediatric). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRN. Product type: Pediatric Position Holder. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5680. Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning. Implant flag: N. Life-sustain/support flag: N.

Official code: PRO. Product type: Anti-Regurgitation Blood Tubing Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5820. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRP. Product type: Balloon Gastrostomy Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRQ. Product type: Esophageal Dilator Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5365. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRR. Product type: Feeding Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRS. Product type: Gastric Colonic Catheter Irrigation Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRT. Product type: Gastric Irrigation And Aspiration Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRU. Product type: Gastric Lavage Kit (Adult Or Pediatric Use). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4370. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRV. Product type: Gastro-Urology Biopsy Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRW. Product type: Gastrointestinal Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRX. Product type: Gastrostomy Guide Wire Placement Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRY. Product type: Gastrostomy Jejunostomy Feeding Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PRZ. Product type: Gastrostomy Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSA. Product type: Laparoscopic Jejunostomy Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSB. Product type: Nasogastric Feed Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSC. Product type: Nasogastric-Gastrojejunal Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSD. Product type: Laparoscopic Gastrostomy Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSE. Product type: Needle Catheter Jejunostomy Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSF. Product type: Non-Balloon Replacement Gastrostomy System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSG. Product type: Percutaneous Endoscopic Gastrostomy Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSH. Product type: Percutaneous Replacement Gastrostomy Tube Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSI. Product type: Perineal Irrigation Kit. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSJ. Product type: Rectal Dilator Kit. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5450. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSK. Product type: Replacement Gastrostomy Feeding Catheter Tray. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5980. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSL. Product type: 25-Oh-Vitamin D Mass Spectrometry Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1840. A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry. Implant flag: N. Life-sustain/support flag: N.

Official code: PSM. Product type: Refractometer For Donor Testing. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2800. For total protein testing of plasma donors to determine eligibility. Implant flag: N. Life-sustain/support flag: N.

Official code: PSN. Product type: Light Based Imaging. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. Emission and collection of light to create an image for medical purposes Implant flag: N. Life-sustain/support flag: N.

Official code: PSP. Product type: Intracranial Pressure & Temperature Monitoring Kit. Official classification: Class II. Official category: Neurology. Regulation number: 882.1620. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PSQ. Product type: Intracardiac Patch Or Pledget, Biologically Derived. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3470. To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature. Implant flag: Y. Life-sustain/support flag: N.

Official code: PSR. Product type: Implanted Phrenic Nerve Stimulator For Central Sleep Apnea. Official classification: Class III. Official category: Unknown. The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep. Implant flag: Y. Life-sustain/support flag: N.

Official code: PSS. Product type: Minoxidil Sulfotransferase Or Isoenzymes Test System. Official classification: Not classified. Official category: Unknown. For measurement of Minoxidil sulfotransferase as an aid in assessing the likelihood that a patient will respond to minoxidil. Implant flag: N. Life-sustain/support flag: N.

Official code: PST. Product type: Aortic Annuloplasty Ring. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3800. To correct annular dilatation and/or maintain annular geometry of the aortic valve. Implant flag: Y. Life-sustain/support flag: Y.

Official code: PSU. Product type: Jak2 Gene Mutation Detection Test. Official classification: Class II. Official category: Medical Genetics. Regulation number: 866.6070. The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors. Implant flag: N. Life-sustain/support flag: N.

Official code: PSV. Product type: Ultrasound Bronchoscope. Official classification: Class II. Official category: Radiology. Regulation number: 892.1550. An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: PSW. Product type: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid. Official classification: Class II. Official category: Radiology. Regulation number: 892.1570. To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). Implant flag: N. Life-sustain/support flag: N.

Official code: PSX. Product type: Chlorine Meter. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5665. These devices are intended to measure chlorine levels in water. Implant flag: N. Life-sustain/support flag: Y.

Official code: PSY. Product type: Whole Slide Imaging System. Official classification: Class II. Official category: Pathology. Regulation number: 864.3700. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear). Implant flag: N. Life-sustain/support flag: N.

Official code: PSZ. Product type: Devices Detecting Influenza A, B, And C Virus Antigens. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3328. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. Implant flag: N. Life-sustain/support flag: N.

Official code: PTA. Product type: Genetic Variant Detection And Health Risk Assessment System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5950. A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease. Implant flag: N. Life-sustain/support flag: N.

Official code: PTB. Product type: Ataxiagraph With Interpretive Software. Official classification: Class I. Official category: Neurology. Regulation number: 882.1030. Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement. Implant flag: N. Life-sustain/support flag: N.

Official code: PTC. Product type: Uric Acid Test System For At Home Prescription Use. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1775. For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: PTD. Product type: Subcutaneous Implanted Apheresis Port. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5965. A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis Implant flag: Y. Life-sustain/support flag: N.

Official code: PTE. Product type: Endoscopic Morcellator Gastroenterology. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1690. For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection) Implant flag: N. Life-sustain/support flag: N.

Official code: PTF. Product type: Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock Implant flag: N. Life-sustain/support flag: N.

Official code: PTG. Product type: Test, Methadone, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine. Implant flag: N. Life-sustain/support flag: N.

Official code: PTH. Product type: Test, Barbiturate, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine. Implant flag: N. Life-sustain/support flag: N.

Official code: PTI. Product type: Non-Coring (Huber) Needle. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums. Implant flag: N. Life-sustain/support flag: N.

Official code: PTJ. Product type: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1640. Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem Implant flag: N. Life-sustain/support flag: N.

Official code: PTK. Product type: Pediatric Esophageal Atresia Anastomosis Device. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.5980. Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter. Implant flag: N. Life-sustain/support flag: Y.

Official code: PTL. Product type: Wire, Guide, Catheter, Exempt. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1330. This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTM. Product type: Syringe, Balloon Inflation, Exempt. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1650. This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTN. Product type: Reservoir, Blood, Cardiopulmonary Bypass, Exempt. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4400. This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTO. Product type: Tester, Auditory Impedance, Exempt. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1090. This product code is the class II exempt counterpart of ETY, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 874.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTP. Product type: Tympanometer, Exempt. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1090. This product code is the class II exempt counterpart of NAS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 874.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTQ. Product type: Endoscopic Magnetic Retriever, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code is the class II exempt counterpart of FCC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTR. Product type: Scissors For Cytoscope, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code is the class II exempt counterpart of KGD, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTS. Product type: Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTT. Product type: Biliary Catheter For Irrigation And Contrast Injection, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5010. This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTU. Product type: Catheter, Peritoneal, Long-Term Indwelling, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: Y. Life-sustain/support flag: N.

Official code: PTV. Product type: Catheter, Peritoneal Dialysis, Single Use, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. This product code is the class II exempt counterpart of FKO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: Y.

Official code: PTW. Product type: System, Peritoneal, Automatic Delivery, Exempt. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5630. This product code is the class II exempt counterpart of FKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: Y.

Official code: PTX. Product type: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4495. This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: Y. Life-sustain/support flag: N.

Official code: PTY. Product type: Computerized Cognitive Assessment Aid, Exempt. Official classification: Class II. Official category: Neurology. Regulation number: 882.1470. This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PTZ. Product type: Colposcope (And Colpomicroscope), Exempt. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1630. This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUA. Product type: Tenaculum, Uterine, Exempt. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code is the class II exempt counterpart of HDC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUB. Product type: Accessory, Assisted Reproduction, Exempt. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6120. This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUC. Product type: Microtools, Assisted Reproduction (Pipettes), Exempt. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6130. This product code is the class II exempt counterpart of MQH, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUD. Product type: Labware, Assisted Reproduction, Exempt. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6160. This product code is the class II exempt counterpart of MQK, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUE. Product type: Biomicroscope, Slit-Lamp, Ac-Powered, Exempt. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1850. This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUF. Product type: Ocular Peg, Exempt. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3320. This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: Y. Life-sustain/support flag: N.

Official code: PUG. Product type: Analyzer, Nitrogen Dioxide, Exempt. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2385. This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 868.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: Y.

Official code: PUH. Product type: Analyzer, Body Composition, Exempt. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUI. Product type: Drape, Surgical, Exempt. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4370. This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: PUJ. Product type: Voriconazole Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3970. A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: PUK. Product type: Administration Set Securement Device. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5210. Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices. Implant flag: N. Life-sustain/support flag: N.

Official code: PUL. Product type: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4100. Used to perform anterior capsulotomy during cataract surgery Implant flag: N. Life-sustain/support flag: N.

Official code: PUM. Product type: Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1251. Embolic protection for transcatheter intracardiac procedures Implant flag: N. Life-sustain/support flag: N.

Official code: PUN. Product type: Lice Removal Kit Containing A Solution. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5960. To remove lice eggs from hair Implant flag: N. Life-sustain/support flag: N.

Official code: PUP. Product type: Endoscope Maintenance System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments. Implant flag: N. Life-sustain/support flag: N.

Official code: PUQ. Product type: Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3510. The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: PUR. Product type: Vacuum Syringe. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid. Implant flag: N. Life-sustain/support flag: N.

Official code: PUU. Product type: Temporary Coil Embolization Assist Device. Official classification: Class II. Official category: Neurology. Regulation number: 882.5955. A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed. Implant flag: N. Life-sustain/support flag: N.

Official code: PUV. Product type: Lymph Node Location System During Sentinel Biopsy Procedure. Official classification: Class III. Official category: Unknown. Locating lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure Implant flag: Y. Life-sustain/support flag: N.

Official code: PUW. Product type: System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens. Official classification: Class II. Official category: Immunology. Regulation number: 866.5750. Intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PUX. Product type: Test, Amphetamine, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3100. The amphetamine test is an in vitro diagnostic test for the qualitative analysis of amphetamine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PUY. Product type: Test, Barbiturate, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3150. The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PUZ. Product type: Test, Benzodiazepine, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3170. The benzodiazepine test is an in vitro diagnostic test for the qualitative analysis of benzodiazepines for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVA. Product type: Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3250. The cocaine and cocaine metabolite test is an in vitro diagnostic test for the qualitative analysis of cocaine and cocaine metabolites for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVB. Product type: Test, Codeine, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3270. The codeine test is an in vitro diagnostic test for the qualitative analysis of codeine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVC. Product type: Test, Lsd, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3580. The LSD test is an in vitro diagnostic test for the qualitative analysis of LSD for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVD. Product type: Test, Methamphetamine, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3610. The methamphetamine test is an in vitro diagnostic test for the qualitative analysis of methamphetamines for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVE. Product type: Test, Methadone, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3620. Test, methadone, employment and insurance testing, exempt FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVF. Product type: Test, Methaqualone, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3630. The methaqualone test is an in vitro diagnostic test for the qualitative analysis of methaqualone for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVG. Product type: Test, Morphine, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3640. The morphine test is an in vitro diagnostic test for the qualitative analysis of morphine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVH. Product type: Test, Opiates, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3650. The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVI. Product type: Test, Propoxyphene, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3700. The propoxyphene test is an in vitro diagnostic test for the qualitative analysis of propoxyphene for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVJ. Product type: Test, Cannabinoid, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3870. The cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVK. Product type: Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3910. The tricyclic antidepressant drugs test is an in vitro diagnostic test for the qualitative analysis of tricyclic antidepressant drugs for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. Implant flag: N. Life-sustain/support flag: N.

Official code: PVL. Product type: Endoscopic Shunt Placement Kit. Official classification: Class II. Official category: Neurology. Regulation number: 882.5550. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVM. Product type: Endoscopic Ventricular Catheter Placement Kit. Official classification: Class II. Official category: Neurology. Regulation number: 882.4100. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVO. Product type: Lumbar Drainage Catheter Kit. Official classification: Class II. Official category: Neurology. Regulation number: 882.5550. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVP. Product type: Neurological Test Kit. Official classification: Class I. Official category: Neurology. Regulation number: 882.1750. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVQ. Product type: Rickettsia Spp. Nucleic Acid Based Detection Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3316. An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government. Implant flag: N. Life-sustain/support flag: N.

Official code: PVR. Product type: D&C Tray. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVS. Product type: Fetal Blood Sampling Kit (Excludes Hiv Testing). Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.1560. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVT. Product type: Maternity Kit. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5435. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVU. Product type: Obstetrical Anesthesia Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5100. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVV. Product type: Paracervical Anesthesia Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5100. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVW. Product type: Pudendal Anesthesia Kit. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5100. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVX. Product type: Vaginal Examination Tray. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVY. Product type: Vasovasostomy Set. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4730. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PVZ. Product type: Non-Stainless Steel Needle. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use. Implant flag: N. Life-sustain/support flag: N.

Official code: PWA. Product type: Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.5150. Designed to be used in conjunction with powered or non-powered breast pumps to apply positive pressure to the breast to aid in milk expression from the breasts of a nursing woman. Implant flag: N. Life-sustain/support flag: N.

Official code: PWB. Product type: Fetal Head Elevator. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4350. To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Implant flag: N. Life-sustain/support flag: N.

Official code: PWC. Product type: General Wellness Product. Official classification: Not classified. Official category: Unknown. General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf Implant flag: N. Life-sustain/support flag: N.

Official code: PWD. Product type: Flow Cytometric Test System For Hematopoietic Neoplasms. Official classification: Class II. Official category: Hematology. Regulation number: 864.7010. Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN) Implant flag: N. Life-sustain/support flag: N.

Official code: PWE. Product type: Computerized Behavioral Therapy Device For Substance Use Disorders. Official classification: Class II. Official category: Neurology. Regulation number: 882.5801. The device is intended to provide cognitive behavioral therapy to treat substance use disorder. Implant flag: N. Life-sustain/support flag: N.

Official code: PWG. Product type: Spinal Fixation System. Official classification: Not classified. Official category: Unknown. Stabilization of the posterior thoracic and lumbar spine Implant flag: Y. Life-sustain/support flag: N.

Official code: PWH. Product type: Administrations Sets With Neuraxial Connectors. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections. Implant flag: N. Life-sustain/support flag: N.

Official code: PWI. Product type: Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4910. Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair Implant flag: N. Life-sustain/support flag: N.

Official code: PWJ. Product type: Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4910. Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence Implant flag: N. Life-sustain/support flag: N.

Official code: PWK. Product type: Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4910. Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair Implant flag: N. Life-sustain/support flag: N.

Official code: PWL. Product type: Oral Surgery Tray. Official classification: Class I. Official category: Dental. Regulation number: 872.4565. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWM. Product type: Admission Kit (Patient Utensil). Official classification: Class I. Official category: General Hospital. Regulation number: 880.6730. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWN. Product type: Baby Care Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5700. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWO. Product type: Blood Administration Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWP. Product type: Blood Borne Pathogen Response Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWQ. Product type: Buret Administration Intravenous Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWR. Product type: Catheter Repair Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5970. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWS. Product type: Chemotherapy Administration Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWT. Product type: Chemotherapy Spill Clean-Up Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWU. Product type: Clean-Up Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6890. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWV. Product type: Delivery Room Apparel Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWW. Product type: Fever Monitoring Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2910. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWX. Product type: Insect Sting Emergency Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5740. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWY. Product type: Lumbar Puncture Tray (Adult & Pediatric). Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PWZ. Product type: Mid-Stream Collection Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6730. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXA. Product type: Oral Administration Set. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6430. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXB. Product type: Percutaneous Introducer Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXC. Product type: Personal Protection Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXD. Product type: Prep Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXE. Product type: Pressure Monitoring (Air/Gas) Kit. Official classification: Class I. Official category: Anesthesiology. Regulation number: 868.2610. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXF. Product type: Sitz Bath Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6730. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXG. Product type: Spill Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6890. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXH. Product type: Thermometer Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2910. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXI. Product type: Thoracentesis Tray. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXJ. Product type: Umbilical Catheter Insertion Tray. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXK. Product type: Vascular Access Port Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5965. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXL. Product type: Venipuncture Kit. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXM. Product type: Vomitus Clean-Up Kit. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6890. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXN. Product type: Basic Set-Up Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXO. Product type: Bone Marrow Biopsy Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXP. Product type: Breast Biopsy / Localization Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXQ. Product type: Burn Dressing Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4022. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXR. Product type: Cement And Bone Removal Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXS. Product type: Cholecystectomy Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXU. Product type: Fluid Drainage Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXV. Product type: General Purpose Instrument Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXW. Product type: Herniorraphy Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXX. Product type: Incision Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXY. Product type: Irrigation Kit (Wounds). Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PXZ. Product type: Laparascopic Sphincterotomy Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYA. Product type: Liver Biopsy Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYB. Product type: Minor Surgical Procedures Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYC. Product type: Paracentesis Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYD. Product type: Pelviscopy Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYE. Product type: Staple Removal Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4760. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYF. Product type: Sterile Puncture Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYG. Product type: Suction Catheter Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYH. Product type: Surgical Retractor Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYI. Product type: Thoracic Catheter Insertion Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4200. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYJ. Product type: Ulcer Wound Tray. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYK. Product type: Venous Ulcer Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYL. Product type: Wound Drainage Kit. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4014. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PYN. Product type: Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3367. The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection. Implant flag: N. Life-sustain/support flag: N.

Official code: PYO. Product type: Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use. Official classification: Class I. Official category: General Hospital. Regulation number: 880.5240. A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin Implant flag: N. Life-sustain/support flag: N.

Official code: PYP. Product type: Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1475. For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions. Implant flag: N. Life-sustain/support flag: N.

Official code: PYQ. Product type: Rfid Chip For Dental Appliance. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6300. The device is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures, and other removable oral appliances. Implant flag: N. Life-sustain/support flag: N.

Official code: PYR. Product type: Neuraxial Administration Set - Intrathecal Delivery. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Neuraxial Administration Sets used to deliver fluids to the intrathecal space. Implant flag: N. Life-sustain/support flag: N.

Official code: PYS. Product type: Zika Virus Serological Reagents (Emergency Use). Official classification: Not classified. Official category: Unknown. Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: PYT. Product type: Device, Fertility Diagnostic, Contraceptive, Software Application. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5370. Designed to monitor and provide fertility information to prevent pregnancy (contraception). Implant flag: N. Life-sustain/support flag: N.

Official code: PYU. Product type: Sponge, Eyelid Cleaning, Powered. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional. Implant flag: N. Life-sustain/support flag: N.

Official code: PYV. Product type: Hospital Continuous Glucose Monitoring System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting. Implant flag: N. Life-sustain/support flag: N.

Official code: PYX. Product type: Temporary Non-Roller Type Right Heart Support Blood Pump. Official classification: Class III. Official category: Cardiovascular. Regulation number: 870.4360. Providing temporary partial or full right heart circulatory support. Implant flag: N. Life-sustain/support flag: Y.

Official code: PZC. Product type: Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue. Official classification: Not classified. Official category: Unknown. An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: PZE. Product type: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated. Official classification: Class III. Official category: Unknown. A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments. Implant flag: N. Life-sustain/support flag: N.

Official code: PZF. Product type: Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System. Official classification: Class II. Official category: Pathology. Regulation number: 866.4001. A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities. Implant flag: N. Life-sustain/support flag: N.

Official code: PZG. Product type: Surgical Eye Tray. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: PZH. Product type: Serpina1 Variant Detection System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5130. This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency. Implant flag: N. Life-sustain/support flag: N.

Official code: PZI. Product type: Prescription Use Blood Glucose Meter For Near-Patient Testing. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1345. Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia. Implant flag: N. Life-sustain/support flag: N.

Official code: PZJ. Product type: Lynch Syndrome Test System. Official classification: Class II. Official category: Immunology. Regulation number: 864.1866. The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome Implant flag: N. Life-sustain/support flag: N.

Official code: PZK. Product type: Light Adjustable Lens (Lal) And Light Delivery Device (Ldd). Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error. Implant flag: Y. Life-sustain/support flag: N.

Official code: PZL. Product type: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4685. Treatment of diabetic foot ulcers Implant flag: N. Life-sustain/support flag: N.

Official code: PZM. Product type: Next Generation Sequencing Based Tumor Profiling Test. Official classification: Class II. Official category: Pathology. Regulation number: 866.6080. A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing. Implant flag: N. Life-sustain/support flag: N.

Official code: PZN. Product type: Placental Growth Factor Test. Official classification: Not classified. Official category: Unknown. For quantitative determination of Placental Growth Factor (PlGF). Implant flag: N. Life-sustain/support flag: N.

Official code: PZO. Product type: Software For Visualization Of Vascular Anatomy And Intravascular Devices. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. Visualization and measurement of blood vessels and intravascular devices for preoperational planning. Implant flag: N. Life-sustain/support flag: N.

Official code: PZP. Product type: Fluid Jet Removal System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 876.4350. The system is used for removal of prostate tissue with a fluid jet. Implant flag: N. Life-sustain/support flag: N.

Official code: PZQ. Product type: General Laparoscopic Power Morcellation Containment System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4825. Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: PZR. Product type: Percutaneous Nerve Stimulator For Opioid Withdrawal. Official classification: Class II. Official category: Neurology. Regulation number: 882.5896. Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders. Implant flag: N. Life-sustain/support flag: N.

Official code: PZS. Product type: Dual Lumen Ecmo Cannula. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4100. Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. Implant flag: N. Life-sustain/support flag: N.

Official code: PZT. Product type: Peripheral Blood Processing Device For Osteoarthritis. Official classification: Not classified. Official category: Unknown. Preparation of autologous anti-inflammatory (AAI) solution from a small sample of peripheral blood for treatment of osteoarthritis. Implant flag: N. Life-sustain/support flag: N.

Official code: PZU. Product type: Bone Marrow Processing Device For Clinical Use. Official classification: Not classified. Official category: Unknown. Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use Implant flag: N. Life-sustain/support flag: N.

Official code: PZV. Product type: Peripheral Blood Processing Device For Clinical Use. Official classification: Not classified. Official category: Unknown. Preparation of autologous platelet rich plasma from a small sample of peripheral blood for clinical use Implant flag: N. Life-sustain/support flag: N.

Official code: PZW. Product type: Catheter Access Cover, Tamper-Resistant. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5970. A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter Implant flag: N. Life-sustain/support flag: N.

Official code: PZX. Product type: Left Atrial Appendage Clip, Implantable. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4300. Intended to occlude the left atrial appendage. Implant flag: Y. Life-sustain/support flag: N.

Official code: PZY. Product type: Additively Manufactured, Preformed, Resin Denture Tooth. Official classification: Class II. Official category: Dental. Regulation number: 872.3590. For the fabrication of preformed denture teeth for use in a denture base Implant flag: N. Life-sustain/support flag: N.

Official code: PZZ. Product type: Digital Pathology Display. Official classification: Class II. Official category: Pathology. Regulation number: 864.3700. The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists. Implant flag: N. Life-sustain/support flag: N.

Official code: QAA. Product type: Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3376. A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection. Implant flag: N. Life-sustain/support flag: N.

Official code: QAB. Product type: Pacing System Analyzer. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3605. The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads. Implant flag: N. Life-sustain/support flag: Y.

Official code: QAC. Product type: Screw Sleeve Bone Fixation Device. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3043. A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct. Implant flag: Y. Life-sustain/support flag: N.

Official code: QAD. Product type: Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3023. Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure. Implant flag: Y. Life-sustain/support flag: N.

Official code: QAF. Product type: Impedance Plethysmograph, Cranial. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. Detect or measure variations in volume in the cranium, using tissue impedance properties. Implant flag: N. Life-sustain/support flag: N.

Official code: QAG. Product type: Endoscopic Electrosurgical Clip Cutting System. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 876.4310. To fragment metallic clips and remove them from the digestive tract. Implant flag: N. Life-sustain/support flag: N.

Official code: QAI. Product type: Powered Microneedle Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4430. A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. Implant flag: N. Life-sustain/support flag: N.

Official code: QAJ. Product type: Cutaneous Electrode Stimulator For Urinary Incontinence. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5330. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence. Implant flag: N. Life-sustain/support flag: N.

Official code: QAK. Product type: Non-Invasive Vagus Nerve Stimulator For Migraine Headache. Official classification: Class II. Official category: Neurology. Regulation number: 882.5892. The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache. Implant flag: N. Life-sustain/support flag: N.

Official code: QAN. Product type: Stent, Iliac Vein. Official classification: Class III. Official category: Unknown. A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen Implant flag: Y. Life-sustain/support flag: Y.

Official code: QAQ. Product type: Adjunctive Predictive Cardiovascular Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2210. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QAR. Product type: Thermal Vestibular Stimulator For Headache. Official classification: Class II. Official category: Neurology. Regulation number: 882.5893. The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache. Implant flag: N. Life-sustain/support flag: N.

Official code: QAS. Product type: Radiological Computer-Assisted Triage And Notification Software. Official classification: Class II. Official category: Radiology. Regulation number: 892.2080. Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification . Implant flag: N. Life-sustain/support flag: N.

Official code: QAT. Product type: Brain Trauma Assessment Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.5830. Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care Implant flag: N. Life-sustain/support flag: N.

Official code: QAU. Product type: Hemostatic Device For Endoscopic Gastrointestinal Use. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4456. Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means. Implant flag: Y. Life-sustain/support flag: N.

Official code: QAV. Product type: High Flow/High Velocity Humidified Oxygen Delivery Device. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5454. Intended to deliver high flow and/or high velocity oxygen with humidification. Implant flag: N. Life-sustain/support flag: N.

Official code: QAW. Product type: Test, Tricyclic Antidepressants, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3910. Intended to measure any of the tricyclic antidepressant drugs in serum or urine. Implant flag: N. Life-sustain/support flag: N.

Official code: QAX. Product type: Hemodialyzer With Expanded Solute Removal Profile. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5862. A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa). Implant flag: N. Life-sustain/support flag: Y.

Official code: QAZ. Product type: Cancer Predisposition Risk Assessment System. Official classification: Class II. Official category: Medical Genetics. Regulation number: 866.6090. A qualitative in vitro molecular diagnostic system used for the detection of select variants in specified cancer-related genes. The device is intended to be used on genomic DNA isolated from human specimens collected by the user. The results of the test provide users with a genetic health risk assessment for developing certain cancers. The test may not include all variants associated with a predisposition of developing cancer and is not intended to describe a person’s overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up. The device is for over-the-counter use. Implant flag: N. Life-sustain/support flag: N.

Official code: QBA. Product type: Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation. Official classification: Class III. Official category: Unknown. To preserve donor lungs prior to transplantation Implant flag: N. Life-sustain/support flag: N.

Official code: QBB. Product type: Placental Alpha Microglobulin-1 Immunoassay. Official classification: Class III. Official category: Unknown. A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor. Implant flag: N. Life-sustain/support flag: N.

Official code: QBC. Product type: External Upper Limb Tremor Stimulator. Official classification: Class II. Official category: Neurology. Regulation number: 882.5897. An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb. Implant flag: N. Life-sustain/support flag: N.

Official code: QBD. Product type: Microbial Nucleic Acid Storage And Stabilization Device. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2950. Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material. Implant flag: N. Life-sustain/support flag: N.

Official code: QBE. Product type: Cranial Sound Monitor. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1875. To non-invasively detect, monitor, record and display acoustic signals in the brain. Implant flag: N. Life-sustain/support flag: N.

Official code: QBF. Product type: Test, Propoxyphene, Over The Counter. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3700. The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample. Implant flag: N. Life-sustain/support flag: N.

Official code: QBG. Product type: Assay, Oral Direct Thrombin Inhibitor. Official classification: Not classified. Official category: Unknown. An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma Implant flag: N. Life-sustain/support flag: N.

Official code: QBH. Product type: Lower Respiratory Microbial Nucleic Acid Detection System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3985. Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QBI. Product type: Acute Coronary Syndrome Event Detector. Official classification: Class III. Official category: Unknown. Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention. Implant flag: Y. Life-sustain/support flag: N.

Official code: QBJ. Product type: Integrated Continuous Glucose Monitoring System, Factory Calibrated. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. Implant flag: N. Life-sustain/support flag: N.

Official code: QBK. Product type: Meprobamate Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3590. A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs). Implant flag: N. Life-sustain/support flag: N.

Official code: QBL. Product type: Piston Syringe Lever. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. Controlled compression of a piston syringe Implant flag: N. Life-sustain/support flag: N.

Official code: QBN. Product type: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3378. The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. Implant flag: N. Life-sustain/support flag: N.

Official code: QBO. Product type: Instruments Designed For Press-Fit Osteochondral Implants. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4505. The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants. Implant flag: N. Life-sustain/support flag: N.

Official code: QBP. Product type: Cap, Device Disinfectant. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5440. Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time Implant flag: N. Life-sustain/support flag: N.

Official code: QBQ. Product type: System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2560. Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium Implant flag: N. Life-sustain/support flag: N.

Official code: QBR. Product type: Intranasal Electrostimulation Device For Dry Eye Symptoms. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5310. This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: QBS. Product type: Radiological Computer Assisted Detection/Diagnosis Software For Fracture. Official classification: Class II. Official category: Radiology. Regulation number: 892.2090. A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user. Implant flag: N. Life-sustain/support flag: N.

Official code: QBT. Product type: Artificial Iris. Official classification: Class III. Official category: Unknown. Artificial iris is intended to be implanted to replace the natural iris of the eye. Implant flag: Y. Life-sustain/support flag: N.

Official code: QBV. Product type: Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2050. To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established. Implant flag: N. Life-sustain/support flag: N.

Official code: QBW. Product type: Surgical Apparel With Material Claims. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity. Implant flag: N. Life-sustain/support flag: N.

Official code: QBX. Product type: Direct Blood Bacterial Nucleic Acid Detection System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3960. Amplification, detection and identification of microbial pathogens directly from whole blood specimens Implant flag: N. Life-sustain/support flag: N.

Official code: QBY. Product type: Positive Airway Pressure System. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5273. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface. Implant flag: N. Life-sustain/support flag: N.

Official code: QBZ. Product type: Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.2750. Instrument used to create pools of whole blood, whole blood lysates, serum, and /or plasma, for use in blood donor screening tests. May include sample preparation steps such as lysing of whole blood samples. Implant flag: N. Life-sustain/support flag: N.

Official code: QCA. Product type: Intracranial Coil-Assist Stent. Official classification: Class III. Official category: Unknown. An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms. Implant flag: Y. Life-sustain/support flag: N.

Official code: QCB. Product type: Phakic Toric Intraocular Lens. Official classification: Class III. Official category: Ophthalmic. Regulation number: 886.3600. Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens. Implant flag: Y. Life-sustain/support flag: N.

Official code: QCC. Product type: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1358. An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors. Implant flag: N. Life-sustain/support flag: N.

Official code: QCD. Product type: Continuous Glucose Monitor, Implanted, Adjunctive Use. Official classification: Class III. Official category: Unknown. The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices. Implant flag: Y. Life-sustain/support flag: N.

Official code: QCF. Product type: Electrical Tongue Stimulator To Treat Motor Deficits. Official classification: Class II. Official category: Neurology. Regulation number: 882.5889. An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits. Implant flag: N. Life-sustain/support flag: N.

Official code: QCG. Product type: Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions. Official classification: Not classified. Official category: Unknown. Intended to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure. These defects may be surgically created from traumatic injury to the bone including bone marrow lesions. Implant flag: Y. Life-sustain/support flag: N.

Official code: QCH. Product type: Assayed Quality Control Material For Clinical Microbiology Assays. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3920. Serologic controls for microbiology assays Implant flag: N. Life-sustain/support flag: N.

Official code: QCI. Product type: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder. Official classification: Class II. Official category: Neurology. Regulation number: 882.5802. External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). Implant flag: N. Life-sustain/support flag: N.

Official code: QCJ. Product type: Closed Loop Auto Titration Device For Oral Appliances. Official classification: Class II. Official category: Dental. Regulation number: 872.5571. A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position. Implant flag: N. Life-sustain/support flag: N.

Official code: QCL. Product type: Acid-Sphingomyelinase (Asm) Newborn Screening Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1488. For quantitative measurement of the activity of acid-sphingomyelinase (ASM) from newborn dried blood spot specimens as an aid in screening newborns for Niemann-Pick disease. Implant flag: N. Life-sustain/support flag: N.

Official code: QCM. Product type: ß-Galactocerebrosidase (Galc) Newborn Screening Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1488. For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease. Implant flag: N. Life-sustain/support flag: N.

Official code: QCR. Product type: Wound Autofluorescence Imaging Device. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4165. A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information. Implant flag: N. Life-sustain/support flag: N.

Official code: QCT. Product type: Scaffold, Dissection Repair. Official classification: Class III. Official category: Unknown. For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries Implant flag: Y. Life-sustain/support flag: Y.

Official code: QCU. Product type: Dengue Virus Antigen Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3945. Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection Implant flag: N. Life-sustain/support flag: N.

Official code: QCW. Product type: Corneal Storage Media With Preservatives Including Anti-Fungal. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4320. Media to preserve human corneas while in storage. Implant flag: N. Life-sustain/support flag: N.

Official code: QCX. Product type: Retrograde Intubation Set. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5095. A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800). Implant flag: N. Life-sustain/support flag: N.

Official code: QCY. Product type: Laser Absorbing Particles. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy. Implant flag: N. Life-sustain/support flag: N.

Official code: QCZ. Product type: Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator. Official classification: Class III. Official category: Unknown. Intended to enable clinicians to prepare an autologous skin cell suspension for application to burn injuries for use when autografting is indicated for definitive wound closure. Implant flag: N. Life-sustain/support flag: Y.

Official code: QDA. Product type: Electrocardiograph Software For Over-The-Counter Use. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2345. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QDB. Product type: Photoplethysmograph Analysis Software For Over-The-Counter Use. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2790. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QDC. Product type: Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies. Official classification: Class II. Official category: Pathology. Regulation number: 866.6100. A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: QDD. Product type: Self-Fitting Air-Conduction Hearing Aid, Prescription. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3325. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid. Implant flag: N. Life-sustain/support flag: N.

Official code: QDF. Product type: Parathyroid Autofluorescence Detection Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4550. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QDG. Product type: Parathyroid Autofluorescence Imaging Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4550. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QDH. Product type: Menopause Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1093. A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women. Implant flag: N. Life-sustain/support flag: N.

Official code: QDI. Product type: Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies. Official classification: Class II. Official category: Medical Genetics. Regulation number: 864.1880. Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional. Implant flag: N. Life-sustain/support flag: N.

Official code: QDJ. Product type: Direct-To-Consumer Access Pharmacogenetic Assessment System. Official classification: Class II. Official category: Medical Genetics. Regulation number: 862.3364. A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users. Implant flag: N. Life-sustain/support flag: N.

Official code: QDK. Product type: Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes. Implant flag: N. Life-sustain/support flag: N.

Official code: QDL. Product type: Integrated Continuous Glucose Monitoring System For Professional Retrospective Use. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices. Implant flag: N. Life-sustain/support flag: N.

Official code: QDM. Product type: Midazolam Syringe. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. Intended for intramuscular injection of midazolam. Implant flag: N. Life-sustain/support flag: N.

Official code: QDO. Product type: Fentanyl And Other Opioid Protection Glove. Official classification: Class I. Official category: General Hospital. Regulation number: 880.6250. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QDP. Product type: Respiratory Panel. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3985. The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection. Implant flag: N. Life-sustain/support flag: N.

Official code: QDQ. Product type: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. Official classification: Class II. Official category: Radiology. Regulation number: 892.2090. A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user. Implant flag: N. Life-sustain/support flag: N.

Official code: QDR. Product type: Plazomicin Test System, Immunoassay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3460. A plazomicin test system is a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary tract infection. Implant flag: N. Life-sustain/support flag: N.

Official code: QDS. Product type: Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System. Official classification: Class II. Official category: Pathology. Regulation number: 866.4001. A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities. Implant flag: N. Life-sustain/support flag: N.

Official code: QDT. Product type: Shoe With Adjustable Sole Units. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3475. Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb Implant flag: N. Life-sustain/support flag: N.

Official code: QDV. Product type: Iol Tray. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4350. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: QDW. Product type: Phaco Kit. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4670. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: QDY. Product type: Vitrectomy Kit. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.4150. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: QDZ. Product type: Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3181. The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies. Implant flag: N. Life-sustain/support flag: N.

Official code: QEA. Product type: Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.1455. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: QEB. Product type: Ventilatory Electrical Impedance Tomograph. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1505. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax. Implant flag: N. Life-sustain/support flag: N.

Official code: QEC. Product type: Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4300. An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree Implant flag: N. Life-sustain/support flag: N.

Official code: QEF. Product type: Pressure Ulcer Management Tool. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.2100. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: QEH. Product type: Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections. Implant flag: N. Life-sustain/support flag: N.

Official code: QEI. Product type: Breast Milk Macronutrients Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1493. A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants. Implant flag: N. Life-sustain/support flag: N.

Official code: QEJ. Product type: Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4100. A flushing and storage solution for vascular autografts is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure. Implant flag: N. Life-sustain/support flag: Y.

Official code: QEK. Product type: Angiographic Coronary Vascular Physiologic Simulation Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1415. An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. Implant flag: N. Life-sustain/support flag: N.

Official code: QEM. Product type: Cerebral Oximeter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2700. Oximeter to measure cerebral tissue saturation Implant flag: N. Life-sustain/support flag: N.

Official code: QEP. Product type: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3393. A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. Implant flag: N. Life-sustain/support flag: N.

Official code: QER. Product type: Camera, Ophthalmic, Slit-Scanning. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1120. An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area. Implant flag: N. Life-sustain/support flag: N.

Official code: QES. Product type: Reherniation Reduction Device. Official classification: Class III. Official category: Unknown. The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc). Implant flag: Y. Life-sustain/support flag: N.

Official code: QEW. Product type: Peripheral Mechanical Thrombectomy With Aspiration. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5150. To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration. Implant flag: N. Life-sustain/support flag: N.

Official code: QEX. Product type: Coronary Mechanical Thrombectomy With Aspiration. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5150. To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration. Implant flag: N. Life-sustain/support flag: N.

Official code: QEY. Product type: Mechanical Thrombolysis Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5150. To mechanically disrupt thrombus and/or debris in the peripheral vasculature. Implant flag: N. Life-sustain/support flag: N.

Official code: QEZ. Product type: Aspiration Thrombectomy Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5150. To remove thrombus from the peripheral and/or coronary vasculature through aspiration. Implant flag: N. Life-sustain/support flag: N.

Official code: QFA. Product type: Assay For Detection Of Proteases In Chronic Wounds. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3231. A device to detect bacterial protease activity in chronic wound fluid is a lateral flow prescription device that may include a sterile swab. The device is intended for use in patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patient are asymptomatic for clinical signs of infection. Implant flag: N. Life-sustain/support flag: N.

Official code: QFB. Product type: Isocapnic Ventilation Device. Official classification: Class II. Official category: General Hospital. Regulation number: 868.5480. An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925). Implant flag: N. Life-sustain/support flag: N.

Official code: QFC. Product type: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4783. A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds. Implant flag: N. Life-sustain/support flag: N.

Official code: QFD. Product type: Tens For Sinus Pain. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Electrical stimulation to relieve pain Implant flag: N. Life-sustain/support flag: N.

Official code: QFF. Product type: Electromechanical Arm For A Transcranial Magnetic Stimulation System. Official classification: Class II. Official category: Neurology. Regulation number: 882.5805. To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system. Implant flag: N. Life-sustain/support flag: N.

Official code: QFG. Product type: Alternate Controller Enabled Insulin Infusion Pump. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 880.5730. An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery. Implant flag: N. Life-sustain/support flag: N.

Official code: QFI. Product type: Synthetic Next-Generation Sequencing Quality Control And Filler Material. Official classification: Not classified. Official category: Unknown. A synthetic next-generation sequencing filler material which contains an adapter-ligated library which allows users to run partial batches of next-generation sequencing assays by adding the material to sample pools to fill in for incomplete batched runs. Implant flag: N. Life-sustain/support flag: N.

Official code: QFJ. Product type: Intravascular Bleed Monitor. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1345. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications. Implant flag: N. Life-sustain/support flag: N.

Official code: QFK. Product type: Tumor Gene Profiling Test. Official classification: Not classified. Official category: Unknown. A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing. Implant flag: N. Life-sustain/support flag: N.

Official code: QFM. Product type: Radiological Computer-Assisted Prioritization Software For Lesions. Official classification: Class II. Official category: Radiology. Regulation number: 892.2080. Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification. Implant flag: N. Life-sustain/support flag: N.

Official code: QFO. Product type: Zika Virus Serological Reagents. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3935. Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: QFP. Product type: Intraoperative Orthopedic Strain Sensor. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3090. A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making. Implant flag: N. Life-sustain/support flag: N.

Official code: QFQ. Product type: Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5982. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract. Implant flag: N. Life-sustain/support flag: N.

Official code: QFR. Product type: Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties. Official classification: Class II. Official category: Hematology. Regulation number: 864.5430. A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients. Implant flag: N. Life-sustain/support flag: N.

Official code: QFS. Product type: Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis. Implant flag: N. Life-sustain/support flag: N.

Official code: QFT. Product type: Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 882.5803. A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: QFV. Product type: Implantable Pulse Generator. Official classification: Class III. Official category: Unknown. Deliver Cardiac Contractility Modulation signals during the absolute refractory period Implant flag: Y. Life-sustain/support flag: Y.

Official code: QFX. Product type: Diagnostic Neurosurgical Microscope Filter. Official classification: Class II. Official category: Neurology. Regulation number: 882.4950. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition. Implant flag: N. Life-sustain/support flag: N.

Official code: QFZ. Product type: Gastroenterology-Urology Accessories To A Biopsy Instrument. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.1080. A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas. Implant flag: N. Life-sustain/support flag: N.

Official code: QGA. Product type: Penile Implant Surgical Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.3500. Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing. Implant flag: N. Life-sustain/support flag: N.

Official code: QGB. Product type: Ureteral Stent Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.4630. Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener. Implant flag: N. Life-sustain/support flag: N.

Official code: QGC. Product type: Suprapubic Catheter Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5100. Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath. Implant flag: N. Life-sustain/support flag: N.

Official code: QGD. Product type: Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5290. Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing. Implant flag: N. Life-sustain/support flag: N.

Official code: QGE. Product type: Biliary Stent, Drain, And Dilator Accessories. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5012. Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube. Implant flag: N. Life-sustain/support flag: N.

Official code: QGG. Product type: Esophageal Sheath With Distal Balloon Anchor. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1510. Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device. Implant flag: N. Life-sustain/support flag: N.

Official code: QGH. Product type: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder. Official classification: Class II. Official category: Neurology. Regulation number: 882.5940. Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. Implant flag: N. Life-sustain/support flag: N.

Official code: QGI. Product type: Air-Handling Apparatus Accessory. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5080. An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches. Implant flag: N. Life-sustain/support flag: N.

Official code: QGJ. Product type: Corneal Inlay Inserter Handle. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4355. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant. Implant flag: N. Life-sustain/support flag: N.

Official code: QGK. Product type: Balloon, Nasal Airway. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction. Implant flag: N. Life-sustain/support flag: N.

Official code: QGL. Product type: Transcutaneous Nerve Stimulator For Adhd. Official classification: Class II. Official category: Neurology. Regulation number: 882.5898. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead. Implant flag: N. Life-sustain/support flag: N.

Official code: QGM. Product type: Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4405. This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: QGN. Product type: Lateral Flow Immunochromatography Assay For Host Infection Biomarkers. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3230. A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: QGO. Product type: Composite Resin Warmer. Official classification: Class I. Official category: Dental. Regulation number: 872.6100. Intended to warm composite materials prior to use Implant flag: N. Life-sustain/support flag: N.

Official code: QGP. Product type: Posterior Ratcheting Rod System. Official classification: Not classified. Official category: Unknown. Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion. Implant flag: Y. Life-sustain/support flag: N.

Official code: QGQ. Product type: Bone Indentation Device. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1600. A bone indentation device is a device that measures resistance to indentation in bone. Implant flag: N. Life-sustain/support flag: N.

Official code: QGT. Product type: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine. Official classification: Class II. Official category: Neurology. Regulation number: 882.5899. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously. Implant flag: N. Life-sustain/support flag: N.

Official code: QGU. Product type: Hemoglobin For Donor Testing. Official classification: Class II. Official category: Hematology. Regulation number: 864.7500. Assays hemoglobin concentration test for blood donors. Implant flag: N. Life-sustain/support flag: N.

Official code: QGX. Product type: General Use Pneumatic Tourniquet. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.5910. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation. Implant flag: N. Life-sustain/support flag: N.

Official code: QGY. Product type: Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system. Implant flag: N. Life-sustain/support flag: N.

Official code: QGZ. Product type: Electrical Tumor Treatment Fields. Official classification: Class III. Official category: Unknown. The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy. Implant flag: N. Life-sustain/support flag: Y.

Official code: QHA. Product type: X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device. Official classification: Class II. Official category: Radiology. Regulation number: 892.1600. X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician. Implant flag: N. Life-sustain/support flag: N.

Official code: QHC. Product type: Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1075. Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes. Implant flag: N. Life-sustain/support flag: N.

Official code: QHE. Product type: Shoulder Arthroplasty Implantation System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3660. Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. Implant flag: N. Life-sustain/support flag: N.

Official code: QHF. Product type: Energy Based Device For Treatment Of Tattoos. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4810. To reduce formation of bubbles during laser treatment of tattoos Implant flag: N. Life-sustain/support flag: N.

Official code: QHG. Product type: Defect Measurement Tool. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4510. Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device. Implant flag: N. Life-sustain/support flag: N.

Official code: QHH. Product type: Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs). Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5340. A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain. Implant flag: N. Life-sustain/support flag: N.

Official code: QHJ. Product type: Sensor, Glucose, Implanted, Non-Adjunctive Use. Official classification: Class III. Official category: Unknown. A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments. Implant flag: Y. Life-sustain/support flag: N.

Official code: QHM. Product type: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations. Official classification: Unclassified (FDA reason code 1). Official category: Microbiology. Regulation number: 610.40. For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens Implant flag: N. Life-sustain/support flag: N.

Official code: QHO. Product type: Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations. Official classification: Unclassified (FDA reason code 1). Official category: Microbiology. Regulation number: 610.40. For the qualitative detection of nucleic acid for infectious disease agents in human specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QHP. Product type: Vertebral Body Tethering System. Official classification: Not classified. Official category: Unknown. Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion Implant flag: Y. Life-sustain/support flag: N.

Official code: QHQ. Product type: Total Shoulder Arthroplasty System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3660. To treat pain and lack of function in the shoulder. Implant flag: Y. Life-sustain/support flag: N.

Official code: QHR. Product type: Blood Grouping Reagent. Official classification: Unclassified (FDA reason code 1). Official category: Hematology. Regulation number: 660.20. For red blood cell antigen typing Implant flag: N. Life-sustain/support flag: N.

Official code: QHS. Product type: Anti-Human Globulin. Official classification: Unclassified (FDA reason code 1). Official category: Hematology. Regulation number: 660.50. For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology Implant flag: N. Life-sustain/support flag: N.

Official code: QHT. Product type: Reagent Red Blood Cells. Official classification: Unclassified (FDA reason code 1). Official category: Hematology. Regulation number: 660.30. For the detection of or identification of human blood-group antibodies Implant flag: N. Life-sustain/support flag: N.

Official code: QHV. Product type: Multiple Osteoarticular Pathogen Antigen Kit. Official classification: Not classified. Official category: Unknown. Qualitative detection of microbial antigen in synovial fluid Implant flag: N. Life-sustain/support flag: N.

Official code: QHW. Product type: Single Lumen Ecmo Cannula. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4100. Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. Implant flag: N. Life-sustain/support flag: N.

Official code: QHX. Product type: Fluoroscopic X-Ray Image Intensifier. Official classification: Class I. Official category: Radiology. Regulation number: 892.1960. To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density. Implant flag: N. Life-sustain/support flag: N.

Official code: QHY. Product type: Solid State Fluoroscopic X-Ray Imager. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density. Implant flag: N. Life-sustain/support flag: N.

Official code: QHZ. Product type: Seal, Cervical, Mechanical, Unpowered. Official classification: Class I. Official category: Obstetrics/Gynecology. Regulation number: 884.1690. Reduce fluid leakage from the cervix during hysteroscopic procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: QIA. Product type: Powered Tongue Scraper. Official classification: Class I. Official category: Dental. Regulation number: 872.6865. The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care. Implant flag: N. Life-sustain/support flag: N.

Official code: QIC. Product type: Hiv-1 Genotyping Assay Using Ngs Technology. Official classification: Class II. Official category: Medical Genetics. Regulation number: 866.3955. The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection. Implant flag: N. Life-sustain/support flag: N.

Official code: QID. Product type: Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens. Official classification: Class II. Official category: Microbiology. Regulation number: 866.4002. A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease. Implant flag: N. Life-sustain/support flag: Y.

Official code: QIG. Product type: Quality Control Material, Genetics, Rna. Official classification: Class II. Official category: Microbiology. Regulation number: 866.5910. RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based controls. Implant flag: N. Life-sustain/support flag: N.

Official code: QIH. Product type: Automated Radiological Image Processing Software. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code. Implant flag: N. Life-sustain/support flag: N.

Official code: QII. Product type: Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices. Implant flag: N. Life-sustain/support flag: N.

Official code: QIJ. Product type: Endoscopic Transhepatic Venous Access Needle. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1050. An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter. Implant flag: N. Life-sustain/support flag: N.

Official code: QIK. Product type: Organ Care System (Ocs) Heart System. Official classification: Class III. Official category: Unknown. A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient. Implant flag: N. Life-sustain/support flag: Y.

Official code: QIM. Product type: Bartonella Spp. Serological Reagents. Official classification: Not classified. Official category: Unknown. Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella spp. in patients suspected of exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: QIN. Product type: Babesia Spp. Serological Reagents. Official classification: Not classified. Official category: Unknown. Tests or reagents used to detect IgG and/or IgM antibodies to Babesia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Babesia spp. in patients suspected of exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: QIO. Product type: Anaplasma Spp. And Ehrlichia Spp. Serological Reagents. Official classification: Not classified. Official category: Unknown. Tests or reagents used to detect IgG and/or IgM antibodies to Anaplasma spp. and/or Ehrlichia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Anaplasma spp. and/or Ehrlichia spp. in patients suspected of exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: QIP. Product type: Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents. Official classification: Not classified. Official category: Unknown. Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: QIQ. Product type: Orientia Spp. (Scrub Typhus) Serological Reagents. Official classification: Not classified. Official category: Unknown. Tests or reagents used to detect IgG and/or IgM antibodies to Orientia spp. (Scrub Typhus) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Orientia spp. in patients suspected of exposure. Implant flag: N. Life-sustain/support flag: N.

Official code: QIR. Product type: Pediatric Hemodialysis System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5861. For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms. Implant flag: N. Life-sustain/support flag: Y.

Official code: QIS. Product type: Esophageal, Mucosal, Electrical Characterization. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1450. The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue. Implant flag: N. Life-sustain/support flag: N.

Official code: QIT. Product type: Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia. Official classification: Class III. Official category: Unknown. Intended to be worn on the surface of the eye in children who have myopia to: • Reduce the rate of progression of myopia, and • Optically correct myopic refractive error. Implant flag: N. Life-sustain/support flag: N.

Official code: QIU. Product type: Intense Pulsed Light Device For Managing Dry Eye. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5201. An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye. Implant flag: N. Life-sustain/support flag: N.

Official code: QIV. Product type: Culture-Based Short-Term Incubation Antimicrobial Resistance Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1655. A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection. Implant flag: N. Life-sustain/support flag: N.

Official code: QIX. Product type: System, Transdermal Delivery, Cder Or Cber Led. Official classification: Not classified. Official category: Unknown. Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect. Implant flag: N. Life-sustain/support flag: N.

Official code: QIY. Product type: Nasal Spray, Systemic Delivery, Cder Or Cber Led. Official classification: Not classified. Official category: Unknown. Nasal spray for systemic delivery of drug substance. Implant flag: N. Life-sustain/support flag: N.

Official code: QIZ. Product type: Material, Implantable For Controlled Release, Cder Or Cber Led. Official classification: Not classified. Official category: Unknown. Implantable material for controlled release of drug substance. Implant flag: N. Life-sustain/support flag: N.

Official code: QJA. Product type: Tympanostomy Tube Delivery Product With Drug. Official classification: Class III. Official category: Unknown. Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia. Implant flag: Y. Life-sustain/support flag: N.

Official code: QJB. Product type: Adjunct Monitor, Protein Calorie Malnutrition. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2770. Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters. Implant flag: N. Life-sustain/support flag: N.

Official code: QJC. Product type: Plaque Disclosing Agent. Official classification: Class I. Official category: Dental. Regulation number: 872.6855. Intended to enhance visualization of the presence of plaque on tooth surfaces. Implant flag: N. Life-sustain/support flag: N.

Official code: QJD. Product type: Absorbable Metallic Bone Fixation Fastener. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3041. An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved. Implant flag: Y. Life-sustain/support flag: Y.

Official code: QJE. Product type: Muscular Dystrophy Newborn Screening Test. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1506. A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy. Implant flag: N. Life-sustain/support flag: N.

Official code: QJF. Product type: Autofluorescence Imaging Adjunct Tool For Wounds. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4550. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QJG. Product type: Device System, Imaging, Tympanic Membrane And Middle Ear. Official classification: Class II. Official category: Radiology. Regulation number: 892.1560. Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space. Implant flag: N. Life-sustain/support flag: N.

Official code: QJH. Product type: Reverse Central Venous Recanalization System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1342. A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods. Implant flag: N. Life-sustain/support flag: N.

Official code: QJI. Product type: Interoperable Automated Glycemic Controller. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1356. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. Implant flag: N. Life-sustain/support flag: N.

Official code: QJJ. Product type: Indirect Bonding Tray. Official classification: Class I. Official category: Dental. Regulation number: 872.5410. A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces. Implant flag: N. Life-sustain/support flag: N.

Official code: QJK. Product type: Intraoral Camera. Official classification: Class II. Official category: Dental. Regulation number: 872.3661. To capture the topographical characteristics of teeth or a stone model Implant flag: N. Life-sustain/support flag: N.

Official code: QJL. Product type: Splint, Intranasal Septal, Cber Led. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4780. Splint, Intranasal Septal, CBER led Implant flag: N. Life-sustain/support flag: N.

Official code: QJN. Product type: Laparoscopic Accessories, Esophageal Sizing. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5360. To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ. Implant flag: N. Life-sustain/support flag: N.

Official code: QJP. Product type: Catheter, Percutaneous, Neurovasculature. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1250. To provide vascular access to the neurovasculature for interventional or diagnostic procedures Implant flag: N. Life-sustain/support flag: N.

Official code: QJQ. Product type: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety. Official classification: Class II. Official category: Neurology. Regulation number: 882.5800. To provide electrical current to the head to treat insomnia and/or anxiety Implant flag: N. Life-sustain/support flag: N.

Official code: QJR. Product type: Reagents, 2019-Novel Coronavirus Nucleic Acid. Official classification: Not classified. Official category: Unknown. Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QJS. Product type: Interoperable Automated Glycemic Controller, Insulin Suspend. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1356. An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. Implant flag: N. Life-sustain/support flag: N.

Official code: QJT. Product type: Rigid Sterilization Container With Software. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6855. The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems. Implant flag: N. Life-sustain/support flag: N.

Official code: QJU. Product type: Image Acquisition And/Or Optimization Guided By Artificial Intelligence. Official classification: Class II. Official category: Radiology. Regulation number: 892.2100. A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality. Implant flag: N. Life-sustain/support flag: N.

Official code: QJX. Product type: Caries Detection Product With Drug Or Biologic. Official classification: Class III. Official category: Unknown. Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic. Implant flag: N. Life-sustain/support flag: N.

Official code: QJY. Product type: Infusion Pump, Drug Specific, Pharmacy-Filled. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5725. A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care. Implant flag: N. Life-sustain/support flag: N.

Official code: QJZ. Product type: Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4100. Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Implant flag: N. Life-sustain/support flag: Y.

Official code: QKA. Product type: Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5510. A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above. Implant flag: N. Life-sustain/support flag: N.

Official code: QKB. Product type: Radiological Image Processing Software For Radiation Therapy. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code. Implant flag: N. Life-sustain/support flag: N.

Official code: QKC. Product type: Interactive Rehabilitation Exercise Device, Prescription Use. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5360. A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform. Implant flag: N. Life-sustain/support flag: N.

Official code: QKD. Product type: Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5670. A prescription device to massage irritable, sore trigger points in the pelvic floor musculature to reduce internal pelvic floor trigger point sensitivity. Implant flag: N. Life-sustain/support flag: N.

Official code: QKE. Product type: Immunoassay, Pregnanediol Glucuronide, Over The Counter. Official classification: Class I. Official category: Clinical Chemistry. Regulation number: 862.1620. Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation Implant flag: N. Life-sustain/support flag: N.

Official code: QKF. Product type: Immunocytochemistry Assay, P16/Ki-67. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician. Implant flag: N. Life-sustain/support flag: N.

Official code: QKH. Product type: Assisted Reproduction Laminar Flow Workstation. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6120. This product code is a class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: QKI. Product type: Media, Reproductive, Exempt. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6180. This product code is the class II exempt counterpart of MQL, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description. Implant flag: N. Life-sustain/support flag: N.

Official code: QKJ. Product type: Stent, Central Venous. Official classification: Class III. Official category: Unknown. A central venous stent is a prescription device for maintaining the luminal diameter of the central veins. Implant flag: Y. Life-sustain/support flag: N.

Official code: QKL. Product type: Lipoaspirate Washing System For Aesthetic Body Contouring. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5040. Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation Implant flag: N. Life-sustain/support flag: N.

Official code: QKM. Product type: A Chemical Vapor Sterilization Multivariable Chemical Indicator. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2800. A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process. Implant flag: N. Life-sustain/support flag: N.

Official code: QKO. Product type: Reagent, Coronavirus Serological. Official classification: Not classified. Official category: Unknown. The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QKP. Product type: Coronavirus Antigen Detection Test System.. Official classification: Not classified. Official category: Unknown. The qualitative detection of coronavirus viral antigens directly from clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QKQ. Product type: Digital Pathology Image Viewing And Management Software. Official classification: Class II. Official category: Pathology. Regulation number: 864.3700. Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QKR. Product type: Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua. Official classification: Not classified. Official category: Unknown. Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download Implant flag: N. Life-sustain/support flag: N.

Official code: QKS. Product type: Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led. Official classification: Not classified. Official category: Unknown. Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route Implant flag: N. Life-sustain/support flag: N.

Official code: QKT. Product type: Clozapine Test System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.3245. A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QKU. Product type: Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs). Official classification: Not classified. Official category: Unknown. For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that don’t have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA Implant flag: N. Life-sustain/support flag: N.

Official code: QKV. Product type: Electromechanical Tear Stimulator. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5305. This device type is a non-implantable device intended to increase tear production via mechanical stimulation. Implant flag: N. Life-sustain/support flag: N.

Official code: QKW. Product type: Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3695. A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty. Implant flag: Y. Life-sustain/support flag: N.

Official code: QKY. Product type: Decontamination Systems For N95 Respirators. Official classification: Not classified. Official category: Unknown. Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QKZ. Product type: Magnetically Maneuvered Capsule Endoscopy System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1310. A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction. Implant flag: N. Life-sustain/support flag: N.

Official code: QLC. Product type: Interleukin 6. Official classification: Not classified. Official category: Unknown. In vitro Diagnostic devices for the quantitative determination of IL-6 (interleukin 6) in human specimens Implant flag: N. Life-sustain/support flag: N.

Official code: QLD. Product type: Protective Barrier Enclosure. Official classification: Not classified. Official category: Unknown. A transparent device designed to cover a patient's head and upper body and incorporates one or more ports through which the HCP's hands are passed to perform medical procedures. Device provides extra layer of barrier protection, in addition to PPE, during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QLE. Product type: Protective Barrier Enclosure With Negative Pressure. Official classification: Not classified. Official category: Unknown. A barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QLF. Product type: On-Body Injector. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QLG. Product type: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems. Implant flag: N. Life-sustain/support flag: N.

Official code: QLH. Product type: System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led. Official classification: Not classified. Official category: Unknown. Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products Implant flag: N. Life-sustain/support flag: N.

Official code: QLI. Product type: Vaporizer, Cder Or Cber Led. Official classification: Not classified. Official category: Unknown. Vaporizers are products that vaporize and deliver drug substance to the site of action through inhalation route. Implant flag: N. Life-sustain/support flag: N.

Official code: QLJ. Product type: Patient Monitor With Independent Remote Display And Operation. Official classification: Not classified. Official category: Unknown. Monitors intended for the remote display and operation of patient physiological monitors, including alarm functionality, signal analysis, and data recording during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QLK. Product type: Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief. Official classification: Class III. Official category: Unknown. Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain. Implant flag: Y. Life-sustain/support flag: N.

Official code: QLL. Product type: Left Ventricular Ejection Fraction Screening Tool. Official classification: Not classified. Official category: Unknown. Electrocardiogram Low Ejection Fraction Tool to be used by healthcare professionals to provide an assessment of Left Ventricular Ejection Fraction (LVEF) for use as a diagnostic aid to screen for potential cardiac complications or underlying cardiac conditions, in adult patients. For use during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QLM. Product type: Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool. Official classification: Not classified. Official category: Unknown. To be used by healthcare providers in the Intensive Care Unit (ICU) for adult patients for the computation of patient status indices as an adjunct to patient monitoring during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QLN. Product type: Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19. Official classification: Not classified. Official category: Unknown. to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved. Implant flag: N. Life-sustain/support flag: Y.

Official code: QLO. Product type: Immunoadsorption Column For Emergency Use. Official classification: Not classified. Official category: Unknown. Extracorporeal carbon dioxide removal from blood for use during declared public health emergency. Implant flag: N. Life-sustain/support flag: Y.

Official code: QLQ. Product type: Manual Instruments Designed For Use With Total Disc Replacement Devices. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4515. The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices. Implant flag: N. Life-sustain/support flag: N.

Official code: QLR. Product type: Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4520. The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use. Implant flag: N. Life-sustain/support flag: N.

Official code: QLT. Product type: Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices. Official classification: Not classified. Official category: Unknown. Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information. Implant flag: N. Life-sustain/support flag: N.

Official code: QLU. Product type: Anti-Factor Xa Activity Test System, Apixaban. Official classification: Class II. Official category: Hematology. Regulation number: 864.7295. A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: QLV. Product type: Field Generator Positioning Device. Official classification: Class I. Official category: Neurology. Regulation number: 882.4565. An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient. Implant flag: N. Life-sustain/support flag: N.

Official code: QLW. Product type: Covid-19 Test Home Collection Kit Devices. Official classification: Not classified. Official category: Unknown. Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit. Implant flag: N. Life-sustain/support flag: N.

Official code: QLX. Product type: Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3183. A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: QLY. Product type: Ophthalmic Syringe. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye. Implant flag: N. Life-sustain/support flag: N.

Official code: QLZ. Product type: Septostomy Catheter, Reprocessed. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5175. To create or enlarge an atrial septal defect in the heart. Implant flag: N. Life-sustain/support flag: N.

Official code: QMA. Product type: Blood Collection Device For Cell-Free Nucleic Acid. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1676. A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing. Implant flag: N. Life-sustain/support flag: N.

Official code: QMC. Product type: Transport Medium, Notified Per The Vtm Guidance. Official classification: Class I. Official category: Microbiology. Regulation number: 866.2390. Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus). Implant flag: N. Life-sustain/support flag: N.

Official code: QMD. Product type: Transcranial Magnetic Stimulation System For Smoking Cessation. Official classification: Class II. Official category: Neurology. Regulation number: 882.5802. Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: QME. Product type: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2785. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QMF. Product type: Mask, Surgical, Eua Authorized. Official classification: Not classified. Official category: Unknown. Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the declared public health emergency. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA's EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA. Implant flag: N. Life-sustain/support flag: N.

Official code: QMG. Product type: Shockwave Intravascular Lithotripsy System. Official classification: Class III. Official category: Unknown. Dilatation of coronary arteries prior to stenting Implant flag: N. Life-sustain/support flag: N.

Official code: QMI. Product type: Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3183. An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions. Implant flag: N. Life-sustain/support flag: N.

Official code: QMJ. Product type: Powered Radiofrequency Toothbrush. Official classification: Class II. Official category: Dental. Regulation number: 872.6866. A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. Implant flag: N. Life-sustain/support flag: N.

Official code: QML. Product type: Anal Fistula Closure Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4835. An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device. Implant flag: Y. Life-sustain/support flag: N.

Official code: QMM. Product type: Hydrophilic Re-Coating Solution. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5919. A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: QMN. Product type: Covid-19 Multi-Analyte Antigen Device. Official classification: Not classified. Official category: Unknown. A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information. Implant flag: N. Life-sustain/support flag: N.

Official code: QMS. Product type: Adjunctive Open Loop Fluid Therapy Recommender. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5600. The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QMT. Product type: Prep Kit – Vaccine Injection. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: QMV. Product type: Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3966. A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors. Implant flag: N. Life-sustain/support flag: N.

Official code: QMW. Product type: Coronary Artery Disease Risk Indicator From Acoustic Heart Signals. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1420. A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QMX. Product type: Label Or Tag, Non-Sterile. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products. Implant flag: N. Life-sustain/support flag: N.

Official code: QMY. Product type: Computerized Behavioral Therapy Device For Treating Symptoms. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5960. A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: QMZ. Product type: Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions. Official classification: Class II. Official category: Neurology. Regulation number: 882.5705. A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post traumatic stress disorder (PTSD). Implant flag: N. Life-sustain/support flag: N.

Official code: QNA. Product type: Ultrasonic Urinary Stone Propulsion Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4690. An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage. Implant flag: N. Life-sustain/support flag: N.

Official code: QNB. Product type: Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein. Official classification: HDE. Official category: Unknown. To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia. Implant flag: N. Life-sustain/support flag: N.

Official code: QNC. Product type: Whole Exome Sequencing Constituent Device. Official classification: Class II. Official category: Medical Genetics. Regulation number: 866.6000. A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device. Implant flag: N. Life-sustain/support flag: N.

Official code: QNE. Product type: Endoscopic Pancreatic Debridement Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4330. An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity. Implant flag: N. Life-sustain/support flag: N.

Official code: QNF. Product type: Laser Activator For Polymerization. Official classification: Class II. Official category: Dental. Regulation number: 872.6070. Intended to polymerize dental restorative resins Implant flag: N. Life-sustain/support flag: N.

Official code: QNH. Product type: Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. The DNA Mismatch Repair Protein Antibody is a qualitative immunohistochemical antibody intended for the assessment of mismatch repair (MMR) proteins in human clinical tissue specimens. The DNA Mismatch Repair Protein Antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QNI. Product type: Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3044. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL. Implant flag: Y. Life-sustain/support flag: N.

Official code: QNJ. Product type: Mass Spectrometry, Microorganism Identification, Blood Culture. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3378. Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry. Implant flag: N. Life-sustain/support flag: N.

Official code: QNK. Product type: Optoacoustic Imaging System. Official classification: Class III. Official category: Unknown. The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis Implant flag: N. Life-sustain/support flag: N.

Official code: QNL. Product type: Medium-Term Adjunctive Predictive Cardiovascular Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2210. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QNM. Product type: Mountable Electromechanical Surgical System For Transluminal Approaches. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4961. A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm. Implant flag: N. Life-sustain/support flag: N.

Official code: QNN. Product type: Prosthesis, Total Talus Replacement, Metal. Official classification: HDE. Official category: Unknown. Replaces the native talus Implant flag: Y. Life-sustain/support flag: N.

Official code: QNO. Product type: Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea. Official classification: Class II. Official category: Dental. Regulation number: 872.5575. A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea. Implant flag: N. Life-sustain/support flag: N.

Official code: QNP. Product type: Gastrointesinal Lesion Software Detection System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1520. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope. Implant flag: N. Life-sustain/support flag: N.

Official code: QNQ. Product type: Low Dead Space Piston Syringe. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: QNR. Product type: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4100. A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. Implant flag: N. Life-sustain/support flag: Y.

Official code: QNS. Product type: Low Dead Space Needle, Single Lumen, Hypodermic. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: QNU. Product type: Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.6000. A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion. Implant flag: N. Life-sustain/support flag: N.

Official code: QNV. Product type: Adjunctive Hemodynamic Indicator With Decision Point. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2220. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. Implant flag: N. Life-sustain/support flag: N.

Official code: QNW. Product type: Reprocessed Bronchoscope. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4680. Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission. Implant flag: N. Life-sustain/support flag: N.

Official code: QNX. Product type: External Compression Device For Internal Jugular Vein Compression. Official classification: Class II. Official category: Neurology. Regulation number: 890.3050. External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use. Implant flag: N. Life-sustain/support flag: N.

Official code: QNY. Product type: Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring. Official classification: Not classified. Official category: Unknown. To be used by healthcare professionals (HCP) in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment with drugs that can prolong QT intervals and may cause life threatening arrhythmias. Device used during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QNZ. Product type: Powered Communication System For Emergency Use. Official classification: Not classified. Official category: Unknown. Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOA. Product type: Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening. Official classification: Not classified. Official category: Unknown. PPG sensor wearable device used in conjunction with thermometers to triage asymptomatic individuals for COVID-19 risk in settings where thermometers are being used for such purpose in accordance with CDC and institutional infection prevention and control guidelines Implant flag: N. Life-sustain/support flag: N.

Official code: QOC. Product type: Temporary Non-Roller Type Left Or Right Heart Support Blood Pump. Official classification: Not classified. Official category: Unknown. Providing temporary partial or full left or right heart circulatory support in addition to other treatments for patient during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOD. Product type: Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure. Official classification: Not classified. Official category: Unknown. Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure for patient having cardiopulmonary failure during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOF. Product type: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3981. A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors. Implant flag: N. Life-sustain/support flag: N.

Official code: QOG. Product type: Injection Data Capture Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5860. An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software. Implant flag: N. Life-sustain/support flag: N.

Official code: QOH. Product type: Extracorporeal System For Carbon Dioxide Removal. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4150. An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors). Implant flag: N. Life-sustain/support flag: N.

Official code: QOI. Product type: Intravenous Catheter Force-Activated Separation Device.. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5220. An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. Implant flag: N. Life-sustain/support flag: N.

Official code: QOJ. Product type: Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only). Official classification: Not classified. Official category: Unknown. Intended to be used for the removal of prosthetic breast implant specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QOK. Product type: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2786. The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QOL. Product type: Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser. Official classification: Class II. Official category: Neurology. Regulation number: 890.5420. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain. Implant flag: N. Life-sustain/support flag: N.

Official code: QON. Product type: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence. Official classification: Class III. Official category: Gastroenterology, Urology. Regulation number: 876.5270. Treatment of chronic fecal incontinence Implant flag: Y. Life-sustain/support flag: N.

Official code: QOO. Product type: Ventilator Tubing And Accessories. Official classification: Not classified. Official category: Unknown. Accessories used with non-continuous ventilators (may include Ventilator Tubing Connector, Elbow Connector for Mask, Breathing Attachment devices) for use during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOP. Product type: Respiratory Humidifier For Emergency Use. Official classification: Not classified. Official category: Unknown. Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device for use during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOQ. Product type: Non-Continuous Ventilator For Emergency Use. Official classification: Not classified. Official category: Unknown. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing for use during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOR. Product type: Continuous Ventilator, Minimal Ventilatory Support. Official classification: Not classified. Official category: Unknown. A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOS. Product type: Continuous Ventilator. Official classification: Not classified. Official category: Unknown. Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings. Implant flag: N. Life-sustain/support flag: N.

Official code: QOT. Product type: Emergency Ventilator. Official classification: Not classified. Official category: Unknown. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOU. Product type: Emergency Resuscitator. Official classification: Not classified. Official category: Unknown. Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOV. Product type: Critical Care Ventilator. Official classification: Not classified. Official category: Unknown. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QOW. Product type: Ventilatory Assistance Helmet. Official classification: Not classified. Official category: Unknown. Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases. Implant flag: N. Life-sustain/support flag: N.

Official code: QOX. Product type: Multi-Patient Circuit Connector. Official classification: Not classified. Official category: Unknown. Accessory to single patient ventilator to allow multi-patient ventilation during declared public health emergency Implant flag: N. Life-sustain/support flag: N.

Official code: QOZ. Product type: Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy. Official classification: Not classified. Official category: Unknown. A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance. Implant flag: N. Life-sustain/support flag: N.

Official code: QPB. Product type: System, Suction, Lipoplasty For Removal. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5040. A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring Implant flag: N. Life-sustain/support flag: N.

Official code: QPC. Product type: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded. Implant flag: N. Life-sustain/support flag: N.

Official code: QPD. Product type: Personal Lubricant Ring. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5300. This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, polyurethane, and/or internal condoms. Implant flag: N. Life-sustain/support flag: N.

Official code: QPE. Product type: Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4880. This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics. Implant flag: N. Life-sustain/support flag: N.

Official code: QPF. Product type: Pediatric Autism Spectrum Disorder Diagnosis Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.1491. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients. Implant flag: N. Life-sustain/support flag: N.

Official code: QPK. Product type: Eua Faceshields. Official classification: Not classified. Official category: Unknown. Authorized faceshields intended for use during the declared public health emergency. Implant flag: N. Life-sustain/support flag: N.

Official code: QPL. Product type: Electromagnetic Stimulator, Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 882.5890. Intended to apply a magnetic-field induced electrical current to treat pain. Implant flag: N. Life-sustain/support flag: N.

Official code: QPN. Product type: Software Algorithm Device To Assist Users In Digital Pathology. Official classification: Class II. Official category: Pathology. Regulation number: 864.3750. A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QPO. Product type: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2952. A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms. Implant flag: N. Life-sustain/support flag: N.

Official code: QPP. Product type: Implantable Post-Surgical Kinematic Measurement Knee Device. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3600. An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: QPQ. Product type: Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3630. A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears. Implant flag: Y. Life-sustain/support flag: N.

Official code: QPR. Product type: Neurological Stimulation For Emergency Use. Official classification: Not classified. Official category: Unknown. authorized nerve stimulation devices for respiratory assistance for use during declared public health emergency use. Implant flag: N. Life-sustain/support flag: N.

Official code: QPS. Product type: Immunoassay For Host Biomarkers Of Infection. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QPT. Product type: Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence. Official classification: Class III. Official category: Unknown. Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve. Implant flag: Y. Life-sustain/support flag: N.

Official code: QPW. Product type: Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube. Official classification: Not classified. Official category: Unknown. A blood collection tube intended for emergency use in healthcare settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19. Implant flag: N. Life-sustain/support flag: N.

Official code: QPX. Product type: Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4683. For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Implant flag: N. Life-sustain/support flag: N.

Official code: QPY. Product type: Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation. Official classification: Class III. Official category: Unknown. Stimulation of the vagus nerve Implant flag: Y. Life-sustain/support flag: N.

Official code: QPZ. Product type: Contact Cooling For Skin Lesion Pain Relief. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4340. For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: QQB. Product type: Prognostic Test For Assessment Of Liver Related Disease Progression. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1622. prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses. Implant flag: N. Life-sustain/support flag: N.

Official code: QQC. Product type: Brain Stimulation Programming Planning Software.. Official classification: Class II. Official category: Neurology. Regulation number: 882.5855. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators. Implant flag: N. Life-sustain/support flag: N.

Official code: QQE. Product type: Image Management Software For Planning Of Otologic And Neurotologic Procedures. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: QQF. Product type: Skin Microneedling Manual/Automated Device (Export Only). Official classification: Not classified. Official category: Unknown. For one-time (1X) use by qualified clinical professionals to cause bio-active effect(s) in skin for aesthetic improvement. Implant flag: N. Life-sustain/support flag: N.

Official code: QQG. Product type: Oropharyngeal Electrical Stimulator. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.5950. An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube. Implant flag: N. Life-sustain/support flag: N.

Official code: QQH. Product type: Powered Insertion System For A Cochlear Implant Electrode Array. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4450. A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea. Implant flag: N. Life-sustain/support flag: N.

Official code: QQI. Product type: Interventional Cardiovascular Implant Simulation Software Device. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1405. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment. Implant flag: N. Life-sustain/support flag: N.

Official code: QQJ. Product type: Applicator, Negative Pressure, External, Ocular. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5000. External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients. Implant flag: N. Life-sustain/support flag: N.

Official code: QQK. Product type: Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation. Official classification: Class III. Official category: Unknown. The device is intended for machine preservation of donor livers prior to transplantation. Implant flag: N. Life-sustain/support flag: Y.

Official code: QQO. Product type: Cranial Measurement Software. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4800. Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods. Implant flag: N. Life-sustain/support flag: N.

Official code: QQQ. Product type: Guide And Positioner, Ophthalmic Drug Delivery Device. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.4300. To provide a guide and/or positioner for filling of a drug delivery device. Implant flag: N. Life-sustain/support flag: N.

Official code: QQR. Product type: Circumcision Device With Stapler. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4530. To cut and suture / staple the prepuce. Implant flag: N. Life-sustain/support flag: N.

Official code: QQS. Product type: Stapler, Skin. Official classification: Class I. Official category: General Hospital. Regulation number: 878.4740. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery. Implant flag: N. Life-sustain/support flag: N.

Official code: QQT. Product type: Immunohistochemistry Assay, Antibody, Ki-67. Official classification: Class III. Official category: Unknown. The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QQU. Product type: Digital Therapy Device For Amblyopia. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5500. A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia. Implant flag: N. Life-sustain/support flag: N.

Official code: QQV. Product type: Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3378. An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS). Implant flag: N. Life-sustain/support flag: N.

Official code: QQX. Product type: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3981. A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors. Implant flag: N. Life-sustain/support flag: N.

Official code: QQY. Product type: Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2190. Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media. Implant flag: N. Life-sustain/support flag: N.

Official code: QRA. Product type: Virtual Reality Behavioral Therapy Device For Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 890.5800. A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display which utilizes a software program containing the behavioral therapy content. Implant flag: N. Life-sustain/support flag: N.

Official code: QRB. Product type: Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy. Official classification: Class III. Official category: Unknown. To relieve pain in patients with diabetic neuropathy Implant flag: Y. Life-sustain/support flag: N.

Official code: QRC. Product type: Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5026. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves. Implant flag: N. Life-sustain/support flag: N.

Official code: QRF. Product type: Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer. Official classification: Class III. Official category: Unknown. Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy. Implant flag: N. Life-sustain/support flag: N.

Official code: QRG. Product type: Ultrasound Guided Nerve Block Assist. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1980. This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia. Implant flag: N. Life-sustain/support flag: N.

Official code: QRH. Product type: Catheter, Balloon, Urethral, Drug-Coated. Official classification: Class III. Official category: Unknown. Dilate urethral strictures Implant flag: N. Life-sustain/support flag: N.

Official code: QRI. Product type: Surgical Planning Software For Neurological Stereotaxic Instruments. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. A surgical planning software for neurological stereotaxic instruments is intended as a stand-alone software device used for pre- and intra-operative planning of stereotactic or image-guided surgeries. Implant flag: N. Life-sustain/support flag: N.

Official code: QRJ. Product type: Laser-Powered Inferior Vena Cava Filter Retrieval Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5125. A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters. Implant flag: N. Life-sustain/support flag: N.

Official code: QRK. Product type: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4850. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: QRL. Product type: Multiple Use Blood Lancet For Single Patient Use Only. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4850. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: QRM. Product type: Multiple Use Blood Lancet For Multiple Patient Use. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4850. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: QRN. Product type: Radiation Therapy Marking Device. Official classification: Class II. Official category: Radiology. Regulation number: 892.5785. A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses. Implant flag: N. Life-sustain/support flag: N.

Official code: QRQ. Product type: Non-Irrigation Endosseous Dental Implant Drill Bits. Official classification: Class I. Official category: Dental. Regulation number: 872.3980. The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation. Implant flag: N. Life-sustain/support flag: N.

Official code: QRR. Product type: Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3046. A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection. Implant flag: Y. Life-sustain/support flag: N.

Official code: QRS. Product type: Device For Sleep Apnea Testing Based On Mandibular Movement. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 868.2376. A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor. Implant flag: N. Life-sustain/support flag: N.

Official code: QRU. Product type: Implant, Resorbable, For Articular Osteochondral Repair. Official classification: Class III. Official category: Unknown. This device is intended to repair knee joint surface cartilage or osteochondral lesions. Implant flag: Y. Life-sustain/support flag: N.

Official code: QRV. Product type: Setmelanotide Eligibility Gene Variant Detection System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1164. A setmelanotide eligibility gene variant detection system is a qualitative in vitro diagnostic device intended to detect germline variants within genes isolated from human specimens for the purpose of identifying patients with obesity who may benefit from treatment with setmelanotide in accordance with the approved therapeutic product labeling. Implant flag: N. Life-sustain/support flag: N.

Official code: QRX. Product type: Continuous Glucose Monitor Informed Insulin Dose Calculator. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1358. A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information. Implant flag: N. Life-sustain/support flag: N.

Official code: QRY. Product type: Dental Navigation System. Official classification: Class II. Official category: Dental. Regulation number: 872.4120. Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: QRZ. Product type: External Condom For Anal Intercourse Or Vaginal Intercourse. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.5305. An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only. Implant flag: N. Life-sustain/support flag: N.

Official code: QSA. Product type: Circulating Tumor Cell (Ctc) Enrichment Device. Official classification: Class II. Official category: Immunology. Regulation number: 866.6110. A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing. Implant flag: N. Life-sustain/support flag: N.

Official code: QSB. Product type: Orthosis, Truncal, Pregnancy. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.3490. Provide abdominal and back support during pregnancy Implant flag: N. Life-sustain/support flag: N.

Official code: QSD. Product type: Posterior Cervical Screw Placement Guide. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3075. A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans. Implant flag: N. Life-sustain/support flag: N.

Official code: QSE. Product type: Alzheimer’S Disease Pathology Assessment Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.5840. In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents. Implant flag: N. Life-sustain/support flag: N.

Official code: QSF. Product type: Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents. Official classification: Class III. Official category: Unknown. The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only. Implant flag: N. Life-sustain/support flag: Y.

Official code: QSH. Product type: Coronavirus Marker Detection. Official classification: Not classified. Official category: Unknown. Coronavirus marker detection Implant flag: N. Life-sustain/support flag: N.

Official code: QSK. Product type: Hybrid Stent Graft, Thoracic Aortic Lesion Treatment. Official classification: Class III. Official category: Unknown. Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair. Implant flag: Y. Life-sustain/support flag: Y.

Official code: QSL. Product type: Brain Temperature Measurement System. Official classification: Class II. Official category: Neurology. Regulation number: 882.1565. A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature. Implant flag: N. Life-sustain/support flag: N.

Official code: QSM. Product type: System, Surgical, Computer Controlled Instrument, Remanufactured. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. As intended with the originally cleared instrument. Implant flag: N. Life-sustain/support flag: N.

Official code: QSN. Product type: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3988. A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections. Implant flag: N. Life-sustain/support flag: N.

Official code: QSO. Product type: Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4040. Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QSQ. Product type: Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms. Official classification: Class II. Official category: Neurology. Regulation number: 882.5888. Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms. Implant flag: N. Life-sustain/support flag: N.

Official code: QSR. Product type: Sacroiliac Screw Placement Guide. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans. Implant flag: N. Life-sustain/support flag: N.

Official code: QSS. Product type: Hiv Self-Tests. Official classification: Class III. Official category: Unknown. Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids. Implant flag: N. Life-sustain/support flag: N.

Official code: QST. Product type: Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3957. Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues. Implant flag: N. Life-sustain/support flag: N.

Official code: QSU. Product type: Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3956. Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues. Implant flag: N. Life-sustain/support flag: N.

Official code: QSV. Product type: Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3957. Human immunodeficiency virus (HIV) Point of Care nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues. Implant flag: N. Life-sustain/support flag: N.

Official code: QSW. Product type: Endoscopic Traction Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.4410. An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal. Implant flag: N. Life-sustain/support flag: N.

Official code: QSX. Product type: Hemostatic Wound Dressing With Thrombin Or Other Biologics. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. To temporarily control bleeding and cover external wounds. Implant flag: N. Life-sustain/support flag: N.

Official code: QSY. Product type: Hemostatic Wound Dressing Without Thrombin Or Other Biologics. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. To temporarily control bleeding and cover external wounds. Implant flag: N. Life-sustain/support flag: N.

Official code: QSZ. Product type: Absorbable Synthetic Wound Dressing. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application. Implant flag: N. Life-sustain/support flag: N.

Official code: QTA. Product type: Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis. Official classification: Not classified. Official category: Unknown. This is an IVD test which utilizes a next generation sequencing (NGS) method performed on a high throughput sequencing platform. This test can identify and differentiate SARS-CoV-2 and support additional genetic analysis, when clinically indicated, from SARS-CoV-2-positive samples identified as positive using an EUA authorized diagnostic test. Testing is limited to designated laboratories. Implant flag: N. Life-sustain/support flag: N.

Official code: QTB. Product type: Nitric Oxide Generator And Delivery System. Official classification: Class III. Official category: Unknown. The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2). Implant flag: N. Life-sustain/support flag: Y.

Official code: QTC. Product type: Adult Portable Bed Rails For Medical Purposes. Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5050. An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics. Implant flag: N. Life-sustain/support flag: N.

Official code: QTD. Product type: Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5983. This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss. Implant flag: Y. Life-sustain/support flag: N.

Official code: QTE. Product type: Thymidine Kinase Activity. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients. Implant flag: N. Life-sustain/support flag: N.

Official code: QTF. Product type: Reprocessed Atherectomy Catheter. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4875. Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission Implant flag: N. Life-sustain/support flag: N.

Official code: QTG. Product type: Infant Supine Sleep System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5690. An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID). Implant flag: N. Life-sustain/support flag: N.

Official code: QTH. Product type: Endoscopic Light-Projecting Measuring Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1530. An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest. Implant flag: N. Life-sustain/support flag: N.

Official code: QTI. Product type: Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs. Implant flag: N. Life-sustain/support flag: N.

Official code: QTK. Product type: Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device. Official classification: HDE. Official category: Unknown. Used to temporarily dilate and increase the diameter of cerebral arteries experiencing symptomatic vasospasm Implant flag: N. Life-sustain/support flag: N.

Official code: QTM. Product type: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3920. Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening. Implant flag: N. Life-sustain/support flag: N.

Official code: QTN. Product type: Orally Ingested Transient Device For Constipation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5940. An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation. Implant flag: N. Life-sustain/support flag: N.

Official code: QTO. Product type: Digital Visual Acuity Test. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1150. A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients. Implant flag: N. Life-sustain/support flag: N.

Official code: QTP. Product type: Reagents, Monkeypox Virus Nucleic Acid.. Official classification: Not classified. Official category: Unknown. Nucleic acid-based in vitro diagnostic devices for the detection of monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens Implant flag: N. Life-sustain/support flag: N.

Official code: QTQ. Product type: Reagents, Non-Variola Orthopoxvirus Nucleic Acid.. Official classification: Not classified. Official category: Unknown. Nucleic acid-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus and/or diagnosis of Monkeypox in human clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: QTT. Product type: Over The Counter Electrical Salivary Stimulatory System. Official classification: Class II. Official category: Dental. Regulation number: 872.5560. Over the Counter Device intended to electrically stimulate a relative increase in saliva production Implant flag: N. Life-sustain/support flag: N.

Official code: QTU. Product type: Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests. Official classification: Not classified. Official category: Unknown. Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY Implant flag: N. Life-sustain/support flag: N.

Official code: QTV. Product type: Mattress And Bed Deck Cover (Medical Purposes). Official classification: Class I. Official category: General Hospital. Regulation number: 880.6190. A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame. Implant flag: N. Life-sustain/support flag: N.

Official code: QTW. Product type: Digital Amsler Grid. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1330. A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients. Implant flag: N. Life-sustain/support flag: N.

Official code: QTY. Product type: Von Willebrand Factor Assay. Official classification: Class II. Official category: Hematology. Regulation number: 864.7293. A von Willebrand factor assay is a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma. Implant flag: N. Life-sustain/support flag: N.

Official code: QTZ. Product type: Radiological Image Processing Software For Ablation Therapy Planning And Evaluation. Official classification: Class II. Official category: Radiology. Regulation number: 892.2050. To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QUA. Product type: Intraoral Cooling Device. Official classification: Class II. Official category: Dental. Regulation number: 872.5590. An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces Implant flag: N. Life-sustain/support flag: N.

Official code: QUB. Product type: Suction Lipoplasty System For Removal And Transfer. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.5040. Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring Implant flag: N. Life-sustain/support flag: N.

Official code: QUD. Product type: Blood Detection Capsule. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1390. Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract. Implant flag: N. Life-sustain/support flag: N.

Official code: QUE. Product type: Spinal Muscular Atrophy Newborn Screening Test System. Official classification: Class II. Official category: Immunology. Regulation number: 866.5980. A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing. Implant flag: N. Life-sustain/support flag: N.

Official code: QUF. Product type: Hearing Aid, Air-Conduction, Over The Counter. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.3300. An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf. Implant flag: N. Life-sustain/support flag: N.

Official code: QUG. Product type: Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3305. A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf. Implant flag: N. Life-sustain/support flag: N.

Official code: QUH. Product type: Self-Fitting Air-Conduction Hearing Aid, Over The Counter. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3325. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf. Implant flag: N. Life-sustain/support flag: N.

Official code: QUJ. Product type: Automated Cryopreservation Storage System. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6120. To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm. Implant flag: N. Life-sustain/support flag: N.

Official code: QUK. Product type: Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.5960. A Human Leukocyte Antigen (HLA) Typing Companion Diagnostic (CDx) Test is a prescription genotyping or phenotyping assay intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product, or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product. Implant flag: N. Life-sustain/support flag: N.

Official code: QUL. Product type: Immunohistochemistry Assay, Antibody, Folr1. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QUM. Product type: Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3958. A human immunodeficiency virus (HIV) viral load monitoring test is an in vitro diagnostic prescription device for the quantitation of the amount of HIV ribonucleic acid (RNA) in human body fluids Implant flag: N. Life-sustain/support flag: N.

Official code: QUN. Product type: Tether Accessory For Use In The Gastrointestinal Tract. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1305. A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract. Implant flag: N. Life-sustain/support flag: N.

Official code: QUO. Product type: Adjunctive Heart Failure Status Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2200. The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QUQ. Product type: Knife, Intraocular Pressure Lowering. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma Implant flag: N. Life-sustain/support flag: N.

Official code: QUR. Product type: Prescription Spectacle Lenses To Reduce The Progression Of Myopia. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5845. Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under § 886.5842. Implant flag: N. Life-sustain/support flag: N.

Official code: QUT. Product type: Deformability Cytometry For Sepsis Risk Assessment. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis Implant flag: N. Life-sustain/support flag: N.

Official code: QUU. Product type: Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3046. A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus. Implant flag: N. Life-sustain/support flag: N.

Official code: QUV. Product type: Phase-Changing Fiducial Marker For Radiation Therapy. Official classification: Class II. Official category: Radiology. Regulation number: 892.5727. A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities. Implant flag: Y. Life-sustain/support flag: N.

Official code: QUW. Product type: Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair. Implant flag: Y. Life-sustain/support flag: N.

Official code: QVA. Product type: Fludeoxyglucose F18-Guided Radiation Therapy System. Official classification: Class II. Official category: Radiology. Regulation number: 892.5060. A fludeoxyglucose F18-guided radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator. Implant flag: N. Life-sustain/support flag: N.

Official code: QVB. Product type: Biological Sterilization Indicator With Indirect Growth Detection. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2806. A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products. Implant flag: N. Life-sustain/support flag: N.

Official code: QVC. Product type: Ventilator Waveform Analysis Software. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5896. Ventilator waveform analysis software is a prescription device that uses software algorithms to analyze mechanical ventilation waveform data to detect, display, and summarize patient-ventilator interactions. The device provides results to healthcare providers as an aid to monitoring or clinical assessment. Implant flag: N. Life-sustain/support flag: N.

Official code: QVD. Product type: Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan. Official classification: Class II. Official category: Radiology. Regulation number: 892.2055. A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan. Implant flag: N. Life-sustain/support flag: N.

Official code: QVE. Product type: Adjunctive Pain Measurement Device For Anesthesiology. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2200. An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making. Implant flag: N. Life-sustain/support flag: N.

Official code: QVF. Product type: Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3982. A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory Implant flag: N. Life-sustain/support flag: N.

Official code: QVG. Product type: Embolization Agent, Vascular. Official classification: Class III. Official category: Unknown. For occluding peripheral vessels Implant flag: Y. Life-sustain/support flag: N.

Official code: QVI. Product type: Screw Sleeve Bone Fixation Device, Spine. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3043. A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct. Implant flag: Y. Life-sustain/support flag: N.

Official code: QVJ. Product type: Low Power Electrosurgical Devices For Skin Lesion Destruction. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions Implant flag: N. Life-sustain/support flag: N.

Official code: QVL. Product type: Absorbable Gel For Intraoperative Use In Spine Surgery. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3047. This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms. Implant flag: Y. Life-sustain/support flag: N.

Official code: QVN. Product type: Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3410. A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus. Implant flag: N. Life-sustain/support flag: N.

Official code: QVO. Product type: Computerized Behavioral Therapy Device For Insomnia. Official classification: Class II. Official category: Neurology. Regulation number: 882.5801. The device is intended to provide cognitive behavioral therapy to treat insomnia. Implant flag: N. Life-sustain/support flag: N.

Official code: QVP. Product type: Sars-Cov-2 Serology Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3983. A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors. Implant flag: N. Life-sustain/support flag: N.

Official code: QVQ. Product type: Extravascular Support For An Arteriovenous Fistula For Vascular Access. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4600. This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery. Implant flag: Y. Life-sustain/support flag: N.

Official code: QVR. Product type: Multiplex Nucleic Acid Detection System For Biothreat Agents. Official classification: Class II. Official category: Immunology. Regulation number: 866.4000. A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens Implant flag: N. Life-sustain/support flag: N.

Official code: QVS. Product type: Breast Implant Suction Retrieval Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4675. A breast implant suction retrieval system is a prescription surgical device that uses vacuum suction to assist in the removal and containment of a ruptured silicone breast implant. Implant flag: N. Life-sustain/support flag: N.

Official code: QVT. Product type: Monitor For Opioid Induced Impairment Of Oxygenation. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2250. A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose Implant flag: N. Life-sustain/support flag: N.

Official code: QVU. Product type: High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.. Official classification: Class II. Official category: Pathology. Regulation number: 866.6095. A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: QVV. Product type: Medial Knee Implanted Shock Absorber. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3610. A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee. Implant flag: Y. Life-sustain/support flag: N.

Official code: QVW. Product type: Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led. Official classification: Not classified. Official category: Unknown. Generator, measurement, and/or delivery system for hyperpolarized MR imaging agents, and accessories, are devices that generate a hyperpolarized MR imaging agent, monitor the dose equivalent volume of the dispensed dose, and/or store, transport or administer the imaging agent to the patient Implant flag: N. Life-sustain/support flag: N.

Official code: QVX. Product type: Skin Patch For Treatment Of Hyperhidrosis. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4425. A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QVY. Product type: Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5151. Reusable hospital mattress pad with integrated mechanical vibrations to be used as adjunctive therapy for neonates and infants with neonatal abstinence syndrome (NAS) or neonatal opioid withdrawal syndrome (NOWS). Implant flag: N. Life-sustain/support flag: N.

Official code: QWA. Product type: Cardiovascular Delivery Catheter System Positioning And Stabilization Device. Official classification: Class I. Official category: Cardiovascular. Regulation number: 870.3955. A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable. Implant flag: N. Life-sustain/support flag: N.

Official code: QWB. Product type: Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3984. An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments. Implant flag: N. Life-sustain/support flag: N.

Official code: QWC. Product type: Pulmonary Stent. Official classification: Class III. Official category: Unknown. A pulmonary stent is a metal scaffold placed via a delivery catheter into the pulmonary artery to maintain the lumen. Implant flag: Y. Life-sustain/support flag: N.

Official code: QWD. Product type: Stimulator, Nerve, For Restless Legs Syndrome. Official classification: Class II. Official category: Neurology. Regulation number: 882.5887. An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome. Implant flag: N. Life-sustain/support flag: N.

Official code: QWE. Product type: Hyperoxia Monitoring Device Adjunct To Pulse Oximetry. Official classification: Class II. Official category: Anesthesiology. Regulation number: 870.2720. A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: QWF. Product type: Tubing, Long Term Support Greater Than 6 Hours. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4100. The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours. Implant flag: N. Life-sustain/support flag: Y.

Official code: QWH. Product type: Prognostic Test For Development Or Progression Of Preeclampsia. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1602. A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease. Implant flag: N. Life-sustain/support flag: N.

Official code: QWI. Product type: Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms. Official classification: Class II. Official category: Neurology. Regulation number: 882.5804. Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms Implant flag: N. Life-sustain/support flag: N.

Official code: QWJ. Product type: Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.3300. For reinforcement of soft tissue where weakness exists in ligament repair Implant flag: Y. Life-sustain/support flag: N.

Official code: QWK. Product type: Prosthesis, Posterior Spinal Elements. Official classification: Class III. Official category: Unknown. This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements. Implant flag: Y. Life-sustain/support flag: N.

Official code: QWL. Product type: Intraoperative Surgical Angle Measurement Tool. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4560. An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy. Implant flag: Y. Life-sustain/support flag: N.

Official code: QWM. Product type: Stent Graft, Bypass, Superficial Femoral Artery. Official classification: Class III. Official category: Unknown. For bypassing stenosis in the superficial femoral artery via the femoral vein Implant flag: Y. Life-sustain/support flag: N.

Official code: QWN. Product type: Stent Graft, Infrapopliteal, Venous Arterialization. Official classification: Class III. Official category: Unknown. For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs Implant flag: Y. Life-sustain/support flag: Y.

Official code: QWO. Product type: Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.. Official classification: Class II. Official category: Radiology. Regulation number: 892.2085. Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process. Implant flag: N. Life-sustain/support flag: N.

Official code: QWP. Product type: Optical Neurosurgical Nerve Locator. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.1820. To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery. Implant flag: N. Life-sustain/support flag: N.

Official code: QWQ. Product type: Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors. Official classification: Class III. Official category: Unknown. An in vitro diagnostic device intended to detect and/or measure pre-existing endogenous antibodies to adeno-associated virus (AAV) viral vectors in patients who may receive AAV vector-based gene therapy products. Implant flag: N. Life-sustain/support flag: N.

Official code: QWR. Product type: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3982. A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory. Implant flag: N. Life-sustain/support flag: N.

Official code: QWS. Product type: Foam Or Gel Chemical Sterilant/High Level Disinfectant. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6886. A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use. Implant flag: N. Life-sustain/support flag: N.

Official code: QWT. Product type: Prognostic Assessment Software Of Mild Cognitive Impairment. Official classification: Class II. Official category: Neurology. Regulation number: 882.1454. Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic too. Implant flag: N. Life-sustain/support flag: N.

Official code: QWU. Product type: Prosthesis, Eyelid Spacer/Graft, Polymer. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.3130. For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area. Implant flag: Y. Life-sustain/support flag: N.

Official code: QWW. Product type: Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5021. A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection. Implant flag: N. Life-sustain/support flag: N.

Official code: QWX. Product type: Active Noise Attenuation System For Infant Incubators. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5405. A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment. Implant flag: N. Life-sustain/support flag: N.

Official code: QWY. Product type: Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator. Official classification: Class III. Official category: Unknown. Intended for use at the patient’s point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo. Implant flag: N. Life-sustain/support flag: N.

Official code: QWZ. Product type: Prognostic Test For Assessment Of Chronic Kidney Disease Progression. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1223. A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product. Implant flag: N. Life-sustain/support flag: N.

Official code: QXA. Product type: Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3230. A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: QXB. Product type: Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia. Official classification: Class III. Official category: Unknown. dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia Implant flag: N. Life-sustain/support flag: N.

Official code: QXC. Product type: Diabetes Digital Therapeutic Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5735. A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication. Implant flag: N. Life-sustain/support flag: N.

Official code: QXD. Product type: Spinal Imaging System For Neuraxial Procedures. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.1985. A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: QXG. Product type: Cooperative Powered Surgical Assist Device For Ent Surgery. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4460. A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument. Implant flag: N. Life-sustain/support flag: N.

Official code: QXH. Product type: Gallbladder Drainage Stent And Delivery System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5016. A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system. Implant flag: Y. Life-sustain/support flag: N.

Official code: QXJ. Product type: Whole Room Microbial Reduction Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6510. A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection. Implant flag: N. Life-sustain/support flag: N.

Official code: QXL. Product type: Cabinet, Emission Computed Tomography System. Official classification: Class II. Official category: Radiology. Regulation number: 892.1200. Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures Implant flag: N. Life-sustain/support flag: N.

Official code: QXM. Product type: Implanted Tibial Electrical Urinary Continence Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5305. An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia. Implant flag: Y. Life-sustain/support flag: N.

Official code: QXN. Product type: Suction Anti-Choking Device As A Second-Line Treatment. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.5400. A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol. Implant flag: N. Life-sustain/support flag: Y.

Official code: QXO. Product type: Cardiovascular Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias. Implant flag: N. Life-sustain/support flag: N.

Official code: QXQ. Product type: Respiratory Accessory Microbial Reduction Device.. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6993. A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions. Implant flag: N. Life-sustain/support flag: N.

Official code: QXR. Product type: Vaginal Hydrogel Packing System. Official classification: Class II. Official category: Radiology. Regulation number: 892.5735. A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery. Implant flag: N. Life-sustain/support flag: N.

Official code: QXS. Product type: Chromogranin A. Official classification: Class II. Official category: Immunology. Regulation number: 866.6010. In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors. Implant flag: N. Life-sustain/support flag: N.

Official code: QXT. Product type: Infliximab Test System. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3115. An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis. Implant flag: N. Life-sustain/support flag: N.

Official code: QXU. Product type: Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5710. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy Implant flag: N. Life-sustain/support flag: N.

Official code: QXV. Product type: Temperature Regulation Device For Esophageal Protection During Cardiac Ablation. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5720. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the esophagus during cardiac ablation. Implant flag: N. Life-sustain/support flag: N.

Official code: QXW. Product type: Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4355. A cryoablation device for local treatment of low-risk breast cancer is a prescription device that uses cold temperatures to destroy a breast tumor and its surrounding tissue. The device is intended as a local treatment and may be used with adjuvant therapies (e.g., endocrine therapy, radiation therapy) to reduce the risk of local disease progression. The device is intended for use in patients with a well-defined solid tumor (e.g., invasive ductal carcinoma) and with low risk of recurrence and metastasis, as determined by clinical risk factors consistent with the indications for use. The device is not intended to treat breast cancers with high risk of local recurrence (e.g., lobular carcinoma), patients with aggressive forms of breast cancer (e.g., breast cancers with inflammatory features), or patients in whom targeted systemic therapy is indicated. Implant flag: N. Life-sustain/support flag: N.

Official code: QXX. Product type: Coronary Artery Disease Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: QXY. Product type: Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1135. An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user. Implant flag: N. Life-sustain/support flag: N.

Official code: QXZ. Product type: Adjunctive Epicardial Vascular Physiologic Status Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2200. The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: QYA. Product type: System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3385. This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use. Implant flag: N. Life-sustain/support flag: N.

Official code: QYC. Product type: Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions. Official classification: Class II. Official category: Hematology. Regulation number: 864.9115. The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment. Implant flag: N. Life-sustain/support flag: N.

Official code: QYD. Product type: Adalimumab Assay. Official classification: Class II. Official category: Clinical Toxicology. Regulation number: 862.3115. An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody Implant flag: N. Life-sustain/support flag: N.

Official code: QYE. Product type: Reduced Ejection Fraction Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: QYF. Product type: Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms). Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1130. The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring. Implant flag: N. Life-sustain/support flag: N.

Official code: QYI. Product type: Ablation Catheter, Renal Denervation. Official classification: Class III. Official category: Unknown. For denervating the renal nerves to lower blood pressure Implant flag: N. Life-sustain/support flag: N.

Official code: QYJ. Product type: Dental Waterline Treatment Cartridge. Official classification: Class I. Official category: Dental. Regulation number: 872.6640. Intended to reduce microbial bioburden in dental unit water lines Implant flag: N. Life-sustain/support flag: N.

Official code: QYK. Product type: Semi-Automated Autologous Skin Graft Harvesting And Application Device. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4795. A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns. Implant flag: N. Life-sustain/support flag: N.

Official code: QYM. Product type: Ophthalmic Needle. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye. Implant flag: N. Life-sustain/support flag: N.

Official code: QYN. Product type: Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use). Official classification: Class I. Official category: Physical Medicine. Regulation number: 890.5775. An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies Implant flag: N. Life-sustain/support flag: N.

Official code: QYO. Product type: Hematopoietic Cell Enrichment Kit. Official classification: Class II. Official category: Immunology. Regulation number: 866.6120. A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow. Implant flag: N. Life-sustain/support flag: N.

Official code: QYQ. Product type: Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal. Official classification: HDE. Official category: Unknown. Replaces the native talus Implant flag: Y. Life-sustain/support flag: N.

Official code: QYT. Product type: Over-The-Counter Covid-19 Antigen Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3984. For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older. Implant flag: N. Life-sustain/support flag: N.

Official code: QYU. Product type: Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2705. An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s). Implant flag: N. Life-sustain/support flag: N.

Official code: QYV. Product type: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm. Official classification: Class II. Official category: Pathology. Regulation number: 864.3900. The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QYW. Product type: Hospital Cardiac Telemetry. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1025. Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and recording of cardiac electrical activity, automated detection of life-threatening arrhythmias or other relevant conditions, and/or alarm generation. Devices may allow remote access and display of electrocardiograms acquired. Devices are intended for patients who require continuous monitoring in hospitals or healthcare facilities, with onsite medical review by qualified personnel at the central monitoring/analysis station followed by immediate notification of onsite qualified medical responders. Devices may be used for patients at elevated risk of serious cardiovascular events that would require prompt intervention. Devices are intended for prescription use only. Implant flag: N. Life-sustain/support flag: Y.

Official code: QYX. Product type: Outpatient Cardiac Telemetry. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1025. Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: QYZ. Product type: At Home Intravaginal Insemination System. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.6110. To deliver semen to the vaginal canal for insemination. Implant flag: N. Life-sustain/support flag: N.

Official code: QZA. Product type: Body Temperature Sensing Software. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2915. Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data. Implant flag: N. Life-sustain/support flag: N.

Official code: QZB. Product type: Software Controlled Endoscope And Instrument Holder. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To hold and position endoscopes and instruments. Implant flag: N. Life-sustain/support flag: N.

Official code: QZC. Product type: External Mechanical Stimulator For The Relief Of Congestion. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.6010. The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion. Implant flag: N. Life-sustain/support flag: N.

Official code: QZF. Product type: Gastrointestinal Capsule Endoscopy Analysis Software Device. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1540. A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system. Implant flag: N. Life-sustain/support flag: N.

Official code: QZG. Product type: Menstrual Blood Collection Device. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1675. Intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing Implant flag: N. Life-sustain/support flag: N.

Official code: QZH. Product type: Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit. Official classification: Class III. Official category: Unknown. A qualitative in vitro molecular test that detects select variants in genomic DNA isolated from human specimens. Results of the test provide users with a genetic risk assessment of developing Opioid Use Disorder (OUD) and are intended to aid users with informed decision-making regarding the use of oral opioids for acute pain relief. The test may not include all variants associated with a risk of developing OUD and is not intended to describe a person’s overall risk of developing OUD. Results from the system are intended to be used in combination with clinical information and should not be the sole determinant in diagnosing, counseling, or making prescribing decisions Implant flag: N. Life-sustain/support flag: N.

Official code: QZI. Product type: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation. Official classification: Class III. Official category: Unknown. For the treatment of atrial fibrillation. Implant flag: N. Life-sustain/support flag: N.

Official code: QZJ. Product type: Immunohistochemistry Assay, Antibody, Claudin 18. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: QZK. Product type: Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions. Official classification: Class III. Official category: Unknown. Endovascular repair of thoracoabdominal and pararenal aortic lesions Implant flag: Y. Life-sustain/support flag: N.

Official code: QZL. Product type: Post-Ablation Tissue Response Prediction Software. Official classification: Class II. Official category: Radiology. Regulation number: 892.2052. A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: QZN. Product type: Multi-Photon Imaging. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4580. To provide visible illumination of the surgical field or the patient Implant flag: N. Life-sustain/support flag: N.

Official code: QZO. Product type: Wearable Vibration Device For Orthopedic Use. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.5895. A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density. Implant flag: N. Life-sustain/support flag: N.

Official code: QZP. Product type: Camera, Ophthalmic, Non-Prescription. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1120. Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional. Implant flag: N. Life-sustain/support flag: N.

Official code: QZS. Product type: Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.1830. A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: QZT. Product type: Gowns And Other Apparel. Official classification: Not classified. Official category: Unknown. Gowns and other apparel are authorized under the EUA for use by HCPs in healthcare settings in accordance with CDC recommendations to protect both HCPs and patients from the transfer of SARS-CoV-2 in low or minimal risk level situations to prevent the spread of COVID-19. Implant flag: N. Life-sustain/support flag: N.

Official code: QZU. Product type: Temporary Embolization Assist Device, Peripheral. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3325. A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed. Implant flag: N. Life-sustain/support flag: N.

Official code: QZV. Product type: Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury. Official classification: Class III. Official category: Unknown. For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT). Implant flag: N. Life-sustain/support flag: Y.

Official code: QZW. Product type: Over-The-Counter Device To Assess Risk Of Sleep Apnea. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.2378. An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor. Implant flag: N. Life-sustain/support flag: N.

Official code: QZX. Product type: Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1650. Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing. Implant flag: N. Life-sustain/support flag: N.

Official code: QZY. Product type: Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3071. A spinal fusion system with 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating is a rigid metallic implant system compromised of single or multiple components intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The device includes a 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body. Implant flag: Y. Life-sustain/support flag: N.

Official code: QZZ. Product type: Limb And Joint Salvage Device With Coating For Bacteria Reduction. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3900. A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products. Implant flag: Y. Life-sustain/support flag: N.

Official code: RAA. Product type: Laser Products (Pre-Standard). Official classification: Not classified. Official category: Unknown. A laser product assembled or manufactured before August 1, 1976

Official code: RAB. Product type: Sunlamp Products (Pre-Standard). Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4635. A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014. Implant flag: N. Life-sustain/support flag: N.

Official code: RAC. Product type: Nondestructive Tests. Official classification: Not classified. Official category: Unknown. Test equipment using ultrasound to analyze an object for defects in commercial or industrial applications

Official code: RAD. Product type: Gauging. Official classification: Not classified. Official category: Unknown. Test equipment using ultrasound to determine thickness of material in commercial or industrial applications

Official code: RAE. Product type: Ranging. Official classification: Not classified. Official category: Unknown. Test equipment used to determine distance to an object using ultrasound in commercial or industrial applications

Official code: RAF. Product type: Cleaner. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to clean objects in commercial or industrial applications

Official code: RAG. Product type: Welder. Official classification: Not classified. Official category: Unknown. Equipment used to weld objects in commercial or industrial applications

Official code: RAH. Product type: Jewelry Cleaner. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to clean jewelry in commercial or household applications

Official code: RAI. Product type: Motion Detector/Occupancy. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to detect movement in commercial or household applications

Official code: RAJ. Product type: Security System. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to provide security in a commercial or household application

Official code: RAK. Product type: Pest Repeller. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to repel pests in a commercial or household application

Official code: RAL. Product type: Massager. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to provide massages in a household application that has no medical claims.

Official code: RAM. Product type: Humidifier. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to disperse water droplets into an area in a household application

Official code: RAN. Product type: Auto Focus Camera. Official classification: Not classified. Official category: Unknown. Photography equipment using ultrasound to provide range to subject

Official code: RAO. Product type: Intrusion Alarm/Security. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to provide security and an intrusion alarm in a commercial or household application

Official code: RAP. Product type: Scientific Use Ultrasound Products. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound in research or scientific application

Official code: RAQ. Product type: Audio System/Radio. Official classification: Not classified. Official category: Unknown. Equipment used to produce audible sound in household entertainment applications

Official code: RAR. Product type: Telephone Ringer. Official classification: Not classified. Official category: Unknown. Equipment used to produce a ring tone on a telephone

Official code: RAS. Product type: Veterinary Diagnostic Ultrasonic Products. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to diagnose disease in veterinary applications

Official code: RAT. Product type: Veterinary Therapy Ultrasonic Products. Official classification: Not classified. Official category: Unknown. Equipment using ultrasound to provide physical therapy in veterinary applications

Official code: RAU. Product type: Night Vision Scope. Official classification: Not classified. Official category: Unknown. An optical device that converts infrared radiation into a visible image through use of an image intensifier tube.

Official code: RAV. Product type: High Voltage Tubes. Official classification: Not classified. Official category: Unknown. Vacuum tubes used in high voltage electronic circuits for purposes other than producing an image.

Official code: RAW. Product type: Cathode Ray Tubes. Official classification: Not classified. Official category: Unknown. A vacuum tube generating a focused beam of electrons that can be deflected by electric fields, magnetic fields or both.

Official code: RAX. Product type: High Voltage Vacuum Switches. Official classification: Not classified. Official category: Unknown. A vacuum tube used for switching high voltages.

Official code: RAY. Product type: Oscilloscope (Exempted). Official classification: Not classified. Official category: Unknown. A device that depicts on a screen periodic changes in an electric quantity, as voltage or current, using a cathode ray tube.

Official code: RAZ. Product type: Television Receiver, Medical Imaging, Color. Official classification: Not classified. Official category: Unknown. A television receiver using a color cathode ray tube to display medical images in colors.

Official code: RBA. Product type: Television Receiver, Medical Imaging, Monochrome. Official classification: Not classified. Official category: Unknown. A television receiver using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color.

Official code: RBB. Product type: Television Receiver, General Purpose, Color. Official classification: Not classified. Official category: Unknown. An electronic product designed to receive and, using a color cathode ray tube, to display a television picture in colors from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.

Official code: RBC. Product type: Television Receiver, General Purpose, Monochrome. Official classification: Not classified. Official category: Unknown. An electronic product designed to receive and, using a monochrome cathode ray tube, to display a television picture in black and white with shades of gray or in different shades of one color from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.

Official code: RBD. Product type: Video Monitor, Medical Imaging, Color. Official classification: Not classified. Official category: Unknown. An electronic product using a color cathode ray tube to display medical images in colors from signals from a computer or electronic medical device.

Official code: RBE. Product type: Video Monitor, General Purpose, Color. Official classification: Not classified. Official category: Unknown. An electronic product using a color cathode ray tube to display general images in colors from signals from a computer or electronic medical device.

Official code: RBF. Product type: Video Monitor, Medical Imaging, Monochrome. Official classification: Not classified. Official category: Unknown. An electronic product using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.

Official code: RBG. Product type: Video Monitor, General Purpose, Monochrome. Official classification: Not classified. Official category: Unknown. An electronic product using a monochrome cathode ray tube to display general images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.

Official code: RBH. Product type: Projector. Official classification: Not classified. Official category: Unknown. Electronic products that use a cathode ray tube or several cathode ray tubes to generate television images which are projected on a screen either from the front or from the rear.

Official code: RBI. Product type: Tv View Finder (Exempted). Official classification: Not classified. Official category: Unknown. An electronic product using a cathode ray tube to display the image seen through the lens of a camcorder. To be exempt the cathode ray tube must operate under 5 kilovolts under the test conditions in the standard (phase iii).

Official code: RBJ. Product type: Cold-Cathode Gas Discharge Tubes. Official classification: Not classified. Official category: Unknown. An electronic device in which electron flow is produced and sustained by ionization of contained gas and ion bombardment of the cathode.

Official code: RBK. Product type: Betatron, Non-Medical. Official classification: Not classified. Official category: Unknown. A betatron used for non-medical applications.

Official code: RBL. Product type: Cyclotron,Non-Medical. Official classification: Not classified. Official category: Unknown. A cyclotron used for non-medical applications.

Official code: RBM. Product type: Microtron, Non-Medical. Official classification: Not classified. Official category: Unknown. A microtron used for non-medical applications.

Official code: RBN. Product type: Synchrotron, Non-Medical. Official classification: Not classified. Official category: Unknown. A synchrotron used for non-medical applications.

Official code: RBO. Product type: Sterilizers, Non-Medical. Official classification: Not classified. Official category: Unknown. A linear accelerator used as a sterilizer for non-medical instruments and applications.

Official code: RBP. Product type: Industrial Accelerator. Official classification: Not classified. Official category: Unknown. An accelerator used for industrial applications.

Official code: RBQ. Product type: Security Accelerator. Official classification: Not classified. Official category: Unknown. A linear accelerator used to non-intrusively search the contents of closed objects such as cargo containers or vehicles for contraband or weapons.

Official code: RBR. Product type: Diagnostic X-Ray Equipment (Noncertified). Official classification: Not classified. Official category: Unknown. Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).

Official code: RBS. Product type: Industrial X-Ray. Official classification: Not classified. Official category: Unknown. An x-ray system used for industrial purposes to which the cabinet x-ray performance standard does not apply (21 cfr 1020.40).

Official code: RBT. Product type: Bottle Fill Checker. Official classification: Not classified. Official category: Unknown. an industrial x-ray system open on the bottom which is used on production lines to determine if containers are filled properly.

Official code: RBU. Product type: X-Ray Thickness Gauge. Official classification: Not classified. Official category: Unknown. An open industrial x-ray system used to measure the thickness of material running through system, usually on a production line.

Official code: RBV. Product type: Security X-Ray System, Open Beam, Small. Official classification: Not classified. Official category: Unknown. An open x-ray system which is used for non-intrusive inspection of containers suspected to contain bombs or other weapons or contraband.

Official code: RBW. Product type: X-Ray Diffraction. Official classification: Not classified. Official category: Unknown. An x-ray system used for x-ray diffraction and used in a laboratory environment.

Official code: RBX. Product type: X-Ray Spectroscopy. Official classification: Not classified. Official category: Unknown. An x-ray system used for x-ray spectroscopy and used in a laboratory environment.

Official code: RBY. Product type: X-Ray Fluorescence. Official classification: Not classified. Official category: Unknown. An x-ray system for x-ray fluorescence and used in a laboratory environment.

Official code: RBZ. Product type: X-Ray Controls ? Combination. Official classification: Not classified. Official category: Unknown. A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure.

Official code: RCA. Product type: X-Ray Controls - Fluoroscopic. Official classification: Not classified. Official category: Unknown. A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating x-ray images and presenting them simultaneously and continuously as visible images.

Official code: RCB. Product type: X-Ray Controls - Radiographic. Official classification: Not classified. Official category: Unknown. A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating and recordingan x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.

Official code: RCC. Product type: C-Arm Fluoroscopic X-Ray System. Official classification: Class II. Official category: Radiology. Regulation number: 892.1650. Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient. Implant flag: N. Life-sustain/support flag: N.

Official code: RCD. Product type: X-Ray Image Receptor. Official classification: Not classified. Official category: Unknown. Any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gageous detector, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term ""image receptor"" shall mean the preselected portion of the device.

Official code: RCE. Product type: Cabinet X-Ray, Industrial. Official classification: Not classified. Official category: Unknown. A cabinet x-ray system used for quality control, non-destructive testing, or some other industrial purpose.

Official code: RCF. Product type: Cabinet X-Ray Explosive Detection Systems. Official classification: Not classified. Official category: Unknown. A cabinet x-ray system used for detection of explosives in closed containers such as airline baggage. Usually these systems use a non-standard x-ray mode to perform this function such as computed tomography.

Official code: RCG. Product type: Cabinet X-Ray, Security (Includes Baggage X-Ray). Official classification: Not classified. Official category: Unknown. A cabinet x-ray system used to examine the contents of containers such as airline baggage, brief cases, and purses to detect weapons or other contraband.

Official code: RCH. Product type: Cabinet X-Ray, Vehicle And Cargo. Official classification: Not classified. Official category: Unknown. A large cabinet x-ray system used to examine pallets full of cargo to find weapons or other contraband, or a very large structure that encompasses entire vehicles being examined.

Official code: RCI. Product type: Cephalometric Devices. Official classification: Not classified. Official category: Unknown. A device intended for the radiographic visualization and measurement of the dimensions of the human head.

Official code: RCJ. Product type: Veterinary Diagnostic X-Ray System. Official classification: Not classified. Official category: Unknown. A system that is uses x-radiation to visualize anatomical structures in veterinary applications.

Official code: RCK. Product type: Veterinary X-Ray Therapy System. Official classification: Not classified. Official category: Unknown. Equipment using x-rays to provide therapy in veterinary applications.

Official code: RCL. Product type: Ion Beam Implanter. Official classification: Not classified. Official category: Unknown. An electronic system that implants ions for fabrication of semiconductor materials.

Official code: RCM. Product type: Microscope (Electron Beam), Non-Medical. Official classification: Not classified. Official category: Unknown. a particle beam system used to view objects or details too small to view with an optical microscope.

Official code: RCN. Product type: Personnel Security Backscatter X-Ray System. Official classification: Not classified. Official category: Unknown. A system intended to find contraband, explosives, and weapons concealed under the clothing of a person through the use of backscattered x-rays.

Official code: RCO. Product type: Personnel Security Transmission X-Ray System. Official classification: Not classified. Official category: Unknown. A system intended to find contraband, explosives, and weapons concealed under the clothing of a person or inside a person through the use of transmitted x-rays.

Official code: RCP. Product type: Vehicle And Cargo X-Ray System, Mobile. Official classification: Not classified. Official category: Unknown. A mobile system, usually mounted in a truck or similar conveyance which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers.

Official code: RCQ. Product type: Vehicle And Cargo X-Ray System, Stationary. Official classification: Not classified. Official category: Unknown. A large system often in its own architectural structure, that does not encompass entire vehicles or cargo containers, which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers which pass through the system.

Official code: RCR. Product type: Microwave Oven, Consumer. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for food preparation, designed for home use.

Official code: RCS. Product type: Microwave Oven, Commercial. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for food preparation, designed for commercial establishments

Official code: RCT. Product type: Tunnel/Conveyor. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for food preparation using a conveyorized or tunnel microwave waveguide.

Official code: RCU. Product type: Vending Machine. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for dispensing heated foods in public areas.

Official code: RCV. Product type: Food Processing. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for food preparation, primarly used in commercial food industry

Official code: RCW. Product type: Materials Processing. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for industry drying/heating of non-food products (non-dielectric heater rf sealers)

Official code: RCX. Product type: Clothes Dryer. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation to warm and dry clothing.

Official code: RCY. Product type: Medical Waste/Sterilizer. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for treating or sterilizing medical waste.

Official code: RCZ. Product type: Materials Processing, Laboratories. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for materials processing, custom designed or modified off-shelf for laboratories.

Official code: RDA. Product type: Dielectric Heaters, Induction Heaters, Rf Sealers. Official classification: Not classified. Official category: Unknown. A machine that utilizes industrial radiofrequency (rf) induction heating with rf fields in frequency range from 2-500 mhz for industrial heating.

Official code: RDB. Product type: Electric Blanket. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave or elf radiation in an electric blanket.

Official code: RDC. Product type: Shavers. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave or elf radiation for shaving hair.

Official code: RDD. Product type: Hair Dryer. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave or elf radiation for drying hair.

Official code: RDE. Product type: Sewing Machine. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave or elf radiation for fabric treatment, incorporated in a sewing machine.

Official code: RDF. Product type: Motor. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave or elf radiation in a motor.

Official code: RDG. Product type: Veterinary, Microwave Medical Products. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for veterinary treatments.

Official code: RDH. Product type: Air Traffic Control. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the air traffic control environment.

Official code: RDI. Product type: Police Radar. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the police traffic control environment.

Official code: RDJ. Product type: Rf Identification. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for rf id tags for security, tracking, inventory control, surveillance, etc.

Official code: RDK. Product type: Electronic Article Surveillance (Eas). Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation used by retailers to prevent theft of merchandise or products

Official code: RDL. Product type: Stun Gun. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation in a stun gun used by law enforcement and military.

Official code: RDM. Product type: Anti-Theft Detector (Non-Eas). Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation (not eas or rfid) for security, tracking, inventory control, surveillance, etc.

Official code: RDN. Product type: Walkie-Talkie. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for communication as in walkie talkies.

Official code: RDO. Product type: Microwave Lan. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for communication and data transmission in a local area network.

Official code: RDP. Product type: Wireless (Cordless) Telephone. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for communication in a wireless, cordless telephone.

Official code: RDQ. Product type: Cb Amateur Radio. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for communication in a cb amateur radio.

Official code: RDS. Product type: Weather Doppler. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for data and measurement transmission in a weather doppler system.

Official code: RDT. Product type: Rf-Excited Lighting. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for rf-excited lighting.

Official code: RDU. Product type: Pest Controller. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for pest control.

Official code: RDV. Product type: Automotive Accessory, Automobile Or Transport Vehicle. Official classification: Not classified. Official category: Unknown. A laser product or product containing a laser that is an automotive or other transport vehicle accessory.

Official code: RDW. Product type: General Purpose Laser Products. Official classification: Not classified. Official category: Unknown. Product, laser, general, emit beam; A laser or product containing a laser that is intended for general purpose use.

Official code: RDX. Product type: Mercury Vapor Lamp. Official classification: Not classified. Official category: Unknown. High intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and manufactured after march 7, 1980.

Official code: RDY. Product type: Metal Halide Lamp. Official classification: Not classified. Official category: Unknown. High-intensity mercury vapor discharge lamp means any lamp including any mercury vapor or metal halide lamp, with the exception of tungsten filament self-ballasted mercury vapor lamp, incorporating a high pressure arc discharge tube that has a fill consisting of mercury and that is contained within an outer envelope.

Official code: RDZ. Product type: Low-Power Laser Light Show Projector. Official classification: Not classified. Official category: Unknown. Product, laser, demo, projector, laser light show/display, class iiia/3r and lower; Laser projection system that incorporates a laser having a maximum radiation output of less than 5mw.

Official code: REA. Product type: High-Power Laser Light Show Projector. Official classification: Not classified. Official category: Unknown. Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.

Official code: REB. Product type: High-Power Laser Light Show. Official classification: Not classified. Official category: Unknown. Product, laser, demo, laser light show/display, class iiib/iv/3b/4; Laser light show or demonstration using laser projection equipment having an output that exceeds 5mw

Official code: REC. Product type: Laser Video Projector. Official classification: Not classified. Official category: Unknown. A raster-scanned digital image projector that uses a scanned laser beam in conjunction with or incorporated in a video display system or projector.

Official code: RED. Product type: Laser Advertising Display System. Official classification: Not classified. Official category: Unknown. Product, laser, demo, system, display, advertising

Official code: REE. Product type: Laser Visual Display - Display Retinal Image, Non-Medical. Official classification: Not classified. Official category: Unknown. Product, laser, display, system, images, direct to retina

Official code: REF. Product type: Suntan Bed. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4635. A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. Implant flag: N. Life-sustain/support flag: N.

Official code: REG. Product type: Suntan Lamp. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4635. A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture. Implant flag: N. Life-sustain/support flag: N.

Official code: REH. Product type: Tabletop Sunlamp System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4635. A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers. Implant flag: N. Life-sustain/support flag: N.

Official code: REI. Product type: Laser Science Education Products. Official classification: Not classified. Official category: Unknown. Product, laser, demo, education, illustrate science principles

Official code: REJ. Product type: Laser Children'S Toy/Novelty Product. Official classification: Not classified. Official category: Unknown. Product, laser, children's toy/novelty

Official code: REK. Product type: Research Laser. Official classification: Not classified. Official category: Unknown. Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research.

Official code: REL. Product type: Guide-Star Laser System. Official classification: Not classified. Official category: Unknown. Product, laser, adaptive-optics telescope focusing accessory, generate artificial star; A laser used for focusing adaptive-optics telescopes.

Official code: REM. Product type: Spectroscopy Instrument. Official classification: Not classified. Official category: Unknown. Product, laser, instrument, spectroscopy; An instrument incorporating a laser for spectroscopic testing or examination

Official code: REN. Product type: Particle-Size Measuring Instrument. Official classification: Not classified. Official category: Unknown. Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining the size or number of particles of particles a test sample.

Official code: REO. Product type: Analytical Measuring And Detection Laser Product. Official classification: Not classified. Official category: Unknown. Product, laser, instrument, analyze/detect chemical species

Official code: REP. Product type: Surveying Laser Product. Official classification: Not classified. Official category: Unknown. Product, laser, surveying, instrument, determine position by measurement of angles

Official code: REQ. Product type: Laser Rangefinders, Time-Of-Flight Speed Measurement Products. Official classification: Not classified. Official category: Unknown. Product, laser, measures speed by time-of-flight. Includes laser range finders.

Official code: RER. Product type: Alignment Laser Product. Official classification: Not classified. Official category: Unknown. Product, laser, alignment, aid positioning or adjusting parts in relation to each other

Official code: RES. Product type: Laser Pointer. Official classification: Not classified. Official category: Unknown. Product, laser, pointer, indicate point of interest; A laser product intended specifically to define a spot or surface for drawing attention to a viewer.

Official code: RET. Product type: Laser Target Designator. Official classification: Not classified. Official category: Unknown. Product, laser, target designator; An optical devices, using a beam of laser radiation that permits the alignment of a firearm-type product such as a gun, cannon, or rocket system with its target.

Official code: REU. Product type: Laser Aiming Product, Visible. Official classification: Not classified. Official category: Unknown. Product, laser, aiming, visible, attached to weapon; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target

Official code: REV. Product type: Laser Aiming Product, Non-Visible. Official classification: Not classified. Official category: Unknown. Product, laser, aiming, infrared, attached to weapon, viewed with night-vision equipment; An optical devices, using an invisible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.

Official code: REW. Product type: Ir Laser Illuminator With Alignment Aid/Night Vision System. Official classification: Not classified. Official category: Unknown. Product, laser, infrared, illuminator with alignment aid, viewed through night-vision equipment

Official code: REX. Product type: Ir Laser Illuminator Only/Night Vision System. Official classification: Not classified. Official category: Unknown. Product, laser, infrared, illuminator only, viewed through night-vision equipment

Official code: REY. Product type: Collision-Avoidance Laser System. Official classification: Not classified. Official category: Unknown. Product, laser, infrared, collision-avoidance system

Official code: REZ. Product type: Laser Traffic Signal. Official classification: Not classified. Official category: Unknown. Product, laser, traffic signal/control

Official code: RFA. Product type: Laser Automotive Lighting & Signals. Official classification: Not classified. Official category: Unknown. Product, laser, automotive, lighting/signals

Official code: RFB. Product type: Ir Laser Intrusion Detection/Security System. Official classification: Not classified. Official category: Unknown. Product, laser, infrared, intrusion detecting, security system

Official code: RFC. Product type: Laser Distance, Detection, Ranging (Lidar). Official classification: Not classified. Official category: Unknown. Product, laser, for distance, detection or ranging measurement.

Official code: RFD. Product type: Laser Weapon (Military Or Police). Official classification: Not classified. Official category: Unknown. Product, laser, weapon (military/police)

Official code: RFE. Product type: Laser Cutter. Official classification: Not classified. Official category: Unknown. A high power laser intended to cut or drill a variety of materials in an industrial or commercial environment.

Official code: RFF. Product type: Laser Welder. Official classification: Not classified. Official category: Unknown. A high power laser intended to weld (join) materials in an industrial or commercial environment.

Official code: RFG. Product type: Microelectronic Mask Or Chip Processing, Checking, And/Or Repair. Official classification: Not classified. Official category: Unknown. A laser intended to process, inspect, and/or repair microelectronic components in an industrial or commercial environment.

Official code: RFI. Product type: Print Industry Plate Maker. Official classification: Not classified. Official category: Unknown. A laser intended to etch, engrave or otherwise create printer's plates used in an industrial or commercial environment.

Official code: RFJ. Product type: Process Control. Official classification: Not classified. Official category: Unknown. A laser used for inspection, counting, or other application intended to monitor a part of the manufacturing process in an industrial or commercial environment. Often incorporated in an automated process system.

Official code: RFK. Product type: Laser Vision. Official classification: Not classified. Official category: Unknown. A laser used for positioning, focusing, inspection, counting, or other application in an industrial or commercial environment. Often incorporated in an automated assembly line system.

Official code: RFL. Product type: Laser Micrometer. Official classification: Not classified. Official category: Unknown. A laser used in high precision dimensional measurements in materials processing.

Official code: RFM. Product type: Laser-Based Material Positioning System. Official classification: Not classified. Official category: Unknown. A laser used in precision positioning of materials in manufacturing in an industrial or commercial environment.

Official code: RFN. Product type: Fiber Optic Communication And Data Transfer. Official classification: Not classified. Official category: Unknown. A laser used in fiber optic communications to transmit data and information.

Official code: RFO. Product type: Ir Free-Space Data Transmit/Control Laser. Official classification: Not classified. Official category: Unknown. A laser used in free space (open air) communications to transmit data and information.

Official code: RFP. Product type: Remote Controller. Official classification: Not classified. Official category: Unknown. A laser used to transmit signals and/or information in order to operate equipment or machinery remotely.

Official code: RFQ. Product type: Interferometric Position Measuring Product. Official classification: Not classified. Official category: Unknown. A laser used as an interferometer for high precision positioning and/or measurements.

Official code: RFR. Product type: Product Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control Product. Official classification: Not classified. Official category: Unknown. A data measurement, data transmission, or remote control product that incorporates a certified class 1 laser.

Official code: RFS. Product type: Reprographics. Official classification: Not classified. Official category: Unknown. A reprographics machine that incorporates a laser utilized to expose internal sensitive components or materials for photocopying text and graphics.

Official code: RFT. Product type: Laser Printer. Official classification: Not classified. Official category: Unknown. A printing machine that incorporates a laser utilized in printing images on paper.

Official code: RFU. Product type: Laser Fax Machine. Official classification: Not classified. Official category: Unknown. A printing machine that incorporates a laser utilized in printing fascimilies of images on paper.

Official code: RFV. Product type: Cd, Cd-Rom Player. Official classification: Not classified. Official category: Unknown. A cd or cd-rom player that utilizes a laser to read data on the compact disc.

Official code: RFW. Product type: Dvd, Dvd-Rom, Bluray, Hd Player. Official classification: Not classified. Official category: Unknown. A dvd, dvd-rom, bluray, or high definition (hd) player that utilizes a laser to read data on the digitally recorded video disc.

Official code: RFX. Product type: Cd-R, Cd-Rw Recorder. Official classification: Not classified. Official category: Unknown. A cd-r or cd-rw recorder machine that utilizes a laser to read and/or write data on the compact disc.

Official code: RFY. Product type: Dvd, Bluray, Or Hd Recorder. Official classification: Not classified. Official category: Unknown. A dvd, bluray, or hd recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: Dvd-r, dvd+r, dvd-ram, dvd-rw, or dvd+rw, or bluray or hd recorders or read/writers.

Official code: RFZ. Product type: Upc Scanner Reader (Bar Code Reader). Official classification: Not classified. Official category: Unknown. A laser used to scan across a bar code to identify the product. Bar code readers can be hand-held accessories, under-counter components incorporated in store check-out systems, or laser scanner systems incorporated in assembly lines used for identification and inventory purposes in manufacturing facilities, warehouses and storage facilities, or other consumer, industrial, health care, or commercial locations.

Official code: RGA. Product type: Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product. Official classification: Not classified. Official category: Unknown. A utility/peripheral laser product that incorporates a certified class 1 laser.

Official code: RGB. Product type: Veterinary Laser. Official classification: Not classified. Official category: Unknown. A laser used for treatment of animals other than human

Official code: RGC. Product type: X-Ray Field Indicator Light (Laser). Official classification: Class I. Official category: Radiology. Regulation number: 892.5780. A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement. Implant flag: N. Life-sustain/support flag: N.

Official code: RGD. Product type: Counterfeit Detection. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used for detection of counterfeit money.

Official code: RGE. Product type: Scientific Crystallography. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used in crystallography for identification.

Official code: RGF. Product type: Forensics. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used in forensics for fingerprint detection.

Official code: RGG. Product type: Forensics Laser. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength laser used in forensics for fingerprint detection.

Official code: RGH. Product type: Toilet Seat Sanitizer. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used for sanitizing toilet seats.

Official code: RGI. Product type: Hand Washing Sanitizer. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used for sanitizing hands after washing.

Official code: RGJ. Product type: Countertop Sanitizer. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used for sanitizing a countertop.

Official code: RGK. Product type: Towel Cleaner. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used for sanitizing towels in a towel washing process.

Official code: RGM. Product type: Photochemical Curing And Adhesive. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.

Official code: RGN. Product type: Photochemical Curing And Adhesive Laser. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength laser light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.

Official code: RGO. Product type: Uv Curing. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.

Official code: RGP. Product type: Black Light. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used to illuminate a fluorescent material to produce fluorescence.

Official code: RGQ. Product type: Cosmetology Uv Lamp. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used to irradiate skin, nails, or hair for cosmetic purposes (excluding tanning).

Official code: RGS. Product type: Water Purifier. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used to sanitize water.

Official code: RGT. Product type: Spectroscopy, Ultraviolet Fluorescence. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source used to stimulate ultraviolet fluorescence.

Official code: RGU. Product type: X-Ray Field Indicator Light Field (Non-Laser). Official classification: Not classified. Official category: Unknown. A noncoherent light source incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.

Official code: RGV. Product type: Veterinary Optical Product. Official classification: Not classified. Official category: Unknown. A noncoherent light source used in veterinary medicine.

Official code: RGW. Product type: Uv/Ir Research. Official classification: Not classified. Official category: Unknown. A noncoherent ultraviolet or infrared light source used in research.

Official code: RGX. Product type: Fluorescent Lamp. Official classification: Not classified. Official category: Unknown. A general purpose fluorescent lamp used for illumination.

Official code: RGY. Product type: Ir Intrusion Detector. Official classification: Not classified. Official category: Unknown. A noncoherent infrared light source used to detect motion to protect against intrusion.

Official code: RGZ. Product type: Ir Security. Official classification: Not classified. Official category: Unknown. A noncoherent infrared light source used for security.

Official code: RHA. Product type: Ir Data Transmit/Control. Official classification: Not classified. Official category: Unknown. A noncoherent infrared source used for data transmission or remote control of another product or machine.

Official code: RHB. Product type: Tungsten Halogen Lamp. Official classification: Not classified. Official category: Unknown. A tungsten halogen lamp.

Official code: RHC. Product type: High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination). Official classification: Not classified. Official category: Unknown. A high pressure mercury vapor, metal halide, or mercury xenon lamp used for a specific purpose and not intended for general purpose illumination. Specific examples are lamps used in scientific and industrial equipment, projection televisions and computer projectors, searchlights, etc.

Official code: RHD. Product type: Ir Remote Controller. Official classification: Not classified. Official category: Unknown. A noncoherent infrared light source used to transmit signals and/or information in order to operate equipment or machinery remotely.

Official code: RHF. Product type: Digital Display Monitor. Official classification: Not classified. Official category: Unknown. A monitor or projector that uses a high intensity light source to illuminate pixels to produce images driven from a digital image source.

Official code: RHG. Product type: Light, Spectrum, Broad (Non-Medical). Official classification: Not classified. Official category: Unknown. A broad spectrum output noncoherent light source intended for general purpose.

Official code: RHH. Product type: Led Lamps Emitting Visible Light Intended To Be Used For Illumination Purposes. Official classification: Not classified. Official category: Unknown. LED lamps emitting predominantly visible and/or white light intended to be used for illumination purposes. These include illumination products, flashlights, finished bulbs or lamps.

Official code: RHI. Product type: Mercury Vapor Lamp, Not Self-Extinguishing, R-Type. Official classification: Not classified. Official category: Unknown. High intensity mercury vapor discharge lamp, not self-extinguishing, r lamp

Official code: RHJ. Product type: Television, Less Than 25kv And Less Than 0.1 Mr/Hr. Official classification: Not classified. Official category: Unknown. Television product, less than 25 kilovolt and less than 0.1 milliroentgen per hour

Official code: RHK. Product type: Laser Marker Or Engraver, Industrial Or Commercial. Official classification: Not classified. Official category: Unknown. A laser intended to mark or engrave an object with text, logos, etc. Using either a mask or a scanned laser beam.

Official code: RHL. Product type: Laser Therapy Product. Official classification: Not classified. Official category: Unknown. Non-surgical laser used on parts of the human body for therapeutic uses, such as pain management.

Official code: RHM. Product type: Image Digitizer. Official classification: Not classified. Official category: Unknown. Product, laser, image digitizer; Converts analog image into digital image format.

Official code: RHN. Product type: Fiber Optic Instrument For Testing Optical Fibers. Official classification: Not classified. Official category: Unknown. A laser used in an instrument for testing and characterizing optical fibers.

Official code: RHO. Product type: Sound Amplification Product. Official classification: Not classified. Official category: Unknown. Intended to amplify environmental sound for non-hearing impaired consumers

Official code: RHP. Product type: Uv Lamp, Germicidal. Official classification: Not classified. Official category: Unknown. An ultraviolet wavelength noncoherent light source intended for use in general purpose, germicidal systems.

Official code: RHQ. Product type: Hologram Displaying Or Creating Laser Product.. Official classification: Not classified. Official category: Unknown. Laser product or product containing a laser that is for the creation or display of holograms for entertainment, artistic, or educational purposes.

Official code: RHR. Product type: Laser Holographic System For Experiments, Research, Or Prototype Development. Official classification: Not classified. Official category: Unknown. A laser holographic system intended to be used for experimental or research purposes; May be prototypes for later manufacturing

Official code: RHS. Product type: Laser Holographic System. Official classification: Not classified. Official category: Unknown. A laser holographic system intended for measurement or process control in manufacturing, inspection, diagnosis or similar engineering activities

Official code: RHT. Product type: Laser Mouse, Trackball, Or Similar. Official classification: Not classified. Official category: Unknown. A mouse or trackball related to a computer or similar electronic tool, used to control the curser on the screen interface.

Official code: RHU. Product type: Led For Signaling/Tracking/Triggering. Official classification: Not classified. Official category: Unknown. Products that incorporate light emitting diodes (LEDs) to be used in relation to a computer or electronic tool, to signal/trigger a sensor, to track movement, or control the product.

Official code: RHV. Product type: Metal Deposition Laser Product. Official classification: Not classified. Official category: Unknown. A Laser driven metal deposition system.

Official code: RHW. Product type: Uv Lamp For Home Or Business Uses. Official classification: Not classified. Official category: Unknown. Uv noncoherent lamp product intended for consumer or commercial use; Including printing, reprographics, and other such processes

Official code: RHX. Product type: Sodium Vapor Lamp. Official classification: Not classified. Official category: Unknown. A sodium vapor lamp is a gas discharge lamp that uses sodium in an excited state to product light. There are two varieties of such lamps: Low pressure and high pressure. It is for general purpose illumination.

Official code: RHY. Product type: Laser Sensing System. Official classification: Not classified. Official category: Unknown. Laser wavefront sensing and/or topographic measurement sensor system.

Official code: RHZ. Product type: 3d Laser Scanning System. Official classification: Not classified. Official category: Unknown. A 3d laser scanning system to be used in an accurate free form process to capture physical objects and produce a complete digital representation of the object for applications such as reverse engineering, prototyping, design, modeling, or others.

Official code: RIA. Product type: High Intensity Lamp. Official classification: Not classified. Official category: Unknown. High intensity mercury vapor or metal halide lamp, intended for general purpose illumination, but of such a design that breakage of an outer envelope will not result in increased uv emissions.

Official code: RIB. Product type: Microscopy Laser Instrument Or Accessory Products. Official classification: Not classified. Official category: Unknown. A laser product for microscopic studies of samples or a microscope laser accessory to assist in such microscopic studies.

Official code: RIC. Product type: Ultrasonic Cutter. Official classification: Not classified. Official category: Unknown. Equipment used to cut objects in commercial or industrial applications.

Official code: RID. Product type: Liquid Crystal Display (Lcd). Official classification: Not classified. Official category: Unknown. A liquid crystal display (LCD) is a flat panel display that uses the light modulating properties of liquid crystal.

Official code: RIE. Product type: Visible Laser Illuminator. Official classification: Not classified. Official category: Unknown. Laser product, visible wavelength, illuminator.

Official code: RIF. Product type: Smart Meter. Official classification: Not classified. Official category: Unknown. An electrical meter that records consumption of a consumable product delivered by a utility company and communicates wirelessly back to the utility company for monitoring and billing purposes.

Official code: RIG. Product type: Laser Illuminated Projector. Official classification: Not classified. Official category: Unknown. A full-frame digital image projector which incorporates lasers and possibly other light sources to illuminate image processing components.

Official code: RIH. Product type: Metal Halide Lamp, Other. Official classification: Not classified. Official category: Unknown. Any metal halide lamp, including sodium vapor, that does not incorporate a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope.

Official code: RII. Product type: Scientific Optical Instrument, Noncoherent. Official classification: Not classified. Official category: Unknown. Any scientific or research instrument that incorporates or uses any noncoherent light source.

Official code: RIJ. Product type: Automotive Radar. Official classification: Not classified. Official category: Unknown. A machine that utilizes microwave radiation for object detection and collision avoidance.

Official code: RIK. Product type: Television Or Monitor, Non-Crt, Non-Medical, Video Display. Official classification: Not classified. Official category: Unknown. An electronic product designed to receive and display television or video signals from broadcast, cable, video player or recorder, computer, or other source. This may be a receiver or monitor or similar. This does not use a cathode ray tube (CRT) to display the image. This would include LED, OLED, LCD, Plasma technology televisions/monitors.

Official code: RIL. Product type: Laser Ignition Tool. Official classification: Not classified. Official category: Unknown. product which is designed to use laser emission to ignite a material.

Official code: RIM. Product type: Laser Marker, Cutter, Or Engraver, Tabletop, Consumer. Official classification: Not classified. Official category: Unknown. A laser intended for consumer, non-industrial, applications to mark, cut, or engrave objects with text, logos, etc. using either a mask or a scanned laser beam in a portable/tabletop/desktop size, often marketed as do it yourself (DIY) tools.

Official code: RIN. Product type: Laser Illuminated Lighting Instrument. Official classification: Not classified. Official category: Unknown. A laser illuminated spotlight used for entertainment lighting effects.

Official code: RIO. Product type: Led Toys And Entertainment Products. Official classification: Not classified. Official category: Unknown. Products that incorporate light emitting diodes (LEDs) to be used in toys or entertaiment products to control, illuminate, or interact with the user. These products include LED "lasertag" toys, and blacklights for home use.

Official code: RIP. Product type: Led Diodes Sold As Components To Be Installed In Finished Electronic Products. Official classification: Not classified. Official category: Unknown. LEDs sold as components to be installed in finished electronic products, such as bare LED diodes and LED diode arrays without control or power modules or standard lamp fitting included. Not including finished bulbs or lamps.

Official code: RIQ. Product type: Low Emission Leds As Indicators Or Decorations. Official classification: Not classified. Official category: Unknown. Finished LED products intended to act as an indicator or for decorative purposes, such as Christmas tree lights or display backlighting. LED product only intending to emit visible radiation at low intensities.

Official code: SAB. Product type: Table Mounted Miniaturized Electromechanical Surgical System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4962. A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms Implant flag: N. Life-sustain/support flag: N.

Official code: SAC. Product type: Adamts13 Activity Test System. Official classification: Class II. Official category: Hematology. Regulation number: 864.7297. An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: SAD. Product type: Japanese Encephalitis Virus Immunological/Serology Test. Official classification: Not classified. Official category: Unknown. Product code for export only Implant flag: N. Life-sustain/support flag: N.

Official code: SAF. Product type: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional. Implant flag: N. Life-sustain/support flag: N.

Official code: SAH. Product type: Magnetic Compression Anastomosis System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4816. A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally. This classification does not include devices intended for weight loss or metabolic disease treatment Implant flag: N. Life-sustain/support flag: N.

Official code: SAI. Product type: Ankle Fusion Cage. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3020. Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use. Implant flag: Y. Life-sustain/support flag: N.

Official code: SAK. Product type: Software Device To Aid In The Prediction Or Diagnosis Of Sepsis. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6316. A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis. Implant flag: N. Life-sustain/support flag: N.

Official code: SAL. Product type: Device, Automated Cell Locating, Bone Marrow. Official classification: Class II. Official category: Hematology. Regulation number: 864.5261. An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type. Implant flag: N. Life-sustain/support flag: N.

Official code: SAM. Product type: Battery-Powered Instruments Charged Through Sterile Barriers. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4820. Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer. Implant flag: N. Life-sustain/support flag: N.

Official code: SAN. Product type: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples. Official classification: Class II. Official category: Microbiology. Regulation number: 866.1650. Automated system that performs antimicrobial susceptibility testing using positive blood culture samples Implant flag: N. Life-sustain/support flag: N.

Official code: SAO. Product type: Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density. Official classification: Class II. Official category: Radiology. Regulation number: 892.1171. This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes. Implant flag: N. Life-sustain/support flag: N.

Official code: SAP. Product type: Computerized Behavioral Therapy Device For Depressive Disorders.. Official classification: Class II. Official category: Neurology. Regulation number: 882.5801. The device is intended to provide computerized behavioral therapy to treat depressive disorders. Implant flag: N. Life-sustain/support flag: N.

Official code: SAQ. Product type: Electromechanical System For Open Microsurgery. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4963. An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm. Implant flag: N. Life-sustain/support flag: N.

Official code: SAR. Product type: Adjunctive Hemodynamic Indicator With Decision Point For Military Use. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2220. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military. Implant flag: N. Life-sustain/support flag: N.

Official code: SAT. Product type: Pulmonary Hypertension Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SAW. Product type: Fluorescence Imaging For Breast Cancer Detection. Official classification: Class III. Official category: Unknown. The combination product consists of an optical imaging agent for injection, and a fluorescence imaging device. The product is intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The imaging device is used with the imaging drug for fluorescence imaging of the lumpectomy cavity. Implant flag: N. Life-sustain/support flag: N.

Official code: SAX. Product type: Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.1600. A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments. Implant flag: N. Life-sustain/support flag: N.

Official code: SAZ. Product type: Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb. Official classification: Class III. Official category: Unknown. As an aid in the management of chronic intractable phantom limb post amputation pain and pain in the residual limb post amputation. Implant flag: Y. Life-sustain/support flag: N.

Official code: SBA. Product type: Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1357. An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site. Implant flag: Y. Life-sustain/support flag: N.

Official code: SBB. Product type: System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection. Official classification: Class III. Official category: Unknown. The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy. Implant flag: N. Life-sustain/support flag: N.

Official code: SBC. Product type: Dental Image Analyzer. Official classification: Class II. Official category: Dental. Regulation number: 872.1770. A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress. Implant flag: N. Life-sustain/support flag: N.

Official code: SBE. Product type: Digital Physical/Chemical Sterilization Process Sensor. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2801. A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result. Implant flag: N. Life-sustain/support flag: N.

Official code: SBF. Product type: Orthopedic Augmented Reality. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view. Implant flag: N. Life-sustain/support flag: N.

Official code: SBG. Product type: In Situ Polymerizing Peripheral Nerve Cap. Official classification: Class II. Official category: Neurology. Regulation number: 882.5260. An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma. Implant flag: Y. Life-sustain/support flag: N.

Official code: SBH. Product type: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1355. An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Implant flag: N. Life-sustain/support flag: N.

Official code: SBI. Product type: Manual Refractor, 3d Display. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1770. A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye. Implant flag: N. Life-sustain/support flag: N.

Official code: SBK. Product type: Artificial Chordae Tendineae Surgical Replacement System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.3490. An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access. Implant flag: Y. Life-sustain/support flag: Y.

Official code: SBL. Product type: Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. Melanoma-associated antigen A4 (MAGE-A4) antibody is a qualitative immunohistochemical antibody, intended for use in the detection of MAGE-A4 protein expression in human clinical tissue specimens. The MAGE A4 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: SBN. Product type: Digital Therapy Device For Convergence Insufficiency. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1290. A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency Implant flag: N. Life-sustain/support flag: N.

Official code: SBO. Product type: Bed-Patient Activity Monitoring System. Official classification: Class I. Official category: General Hospital. Regulation number: 880.2400. A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or other signal when patient activity deviates from assigned pressure prevention parameters. Implant flag: N. Life-sustain/support flag: N.

Official code: SBP. Product type: Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3171. A simple point-of-care nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) test is an in vitro diagnostic device that is intended for prescription use for the detection of HCV RNA in clinical specimens as an aid in the diagnosis of HCV infection or as an aid in the management of HCV-infected patients, including individuals without antibodies to HCV. This device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The test is not intended for use as a donor screening test for the presence of HCV RNA in blood, blood products, or tissue donors. Implant flag: N. Life-sustain/support flag: N.

Official code: SBQ. Product type: Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SBS. Product type: Laryngeal Injection Set With Led Light. Official classification: Class I. Official category: Ear, Nose, Throat. Regulation number: 874.4420. A light guided laryngeal injection set is an ear, nose, and throat manual surgical instrument and is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar Implant flag: N. Life-sustain/support flag: N.

Official code: SBT. Product type: Device To Detect Microbial Colonization Directly From Clinical Specimens.. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3967. A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings. Implant flag: N. Life-sustain/support flag: N.

Official code: SBX. Product type: Software For Endoscopy Procedure Metrics. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Software that analyzes gastrointestinal (i.e., esophagus, stomach, small bowel, and colon) endoscopy procedure¿data to assess or document the procedure metrics such as completeness of the endoscopic procedure conducted by an appropriately trained healthcare provider; and to provide feedback to the healthcare provider on procedural metrics that are part of the standard of care. The health care provider is responsible for verifying and interpreting the procedural metric data with regard to patient management. The software function does not aid the healthcare provider in the detection of lesions nor does the software function aid the healthcare provider to identify characteristics of the patient, anatomy, or lesion that may be used for diagnosis of a disease or condition.¿The software does not output treatment recommendations. Implant flag: N. Life-sustain/support flag: N.

Official code: SBY. Product type: High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids. Official classification: Class II. Official category: Pathology. Regulation number: 866.6085. A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product. Implant flag: N. Life-sustain/support flag: N.

Official code: SBZ. Product type: Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3986. Test for detection of antibodies associated with syphilis performed by lay users is an in vitro diagnostic device used for detection of antibodies in clinical specimens for use in home settings, or similar environments. The device is intended to aid in diagnosis of syphilis and intended for prescription use or over-the-counter use. Implant flag: N. Life-sustain/support flag: N.

Official code: SCA. Product type: Multi-Analyte Respiratory Virus Antigen Detection Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3987. A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport. Implant flag: N. Life-sustain/support flag: N.

Official code: SCB. Product type: Deflation Needle For Removal Of Intragastric Balloon. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1550. Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically. Implant flag: N. Life-sustain/support flag: N.

Official code: SCE. Product type: Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule. Official classification: Not classified. Official category: Unknown. Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCF. Product type: Ldt, Unmet Need Within An Integrated Healthcare System. Official classification: Not classified. Official category: Unknown. Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCG. Product type: Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule. Official classification: Not classified. Official category: Unknown. When a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting CLIA’s regulatory requirements to perform high complexity testing modifies another manufacturer’s 510(k) cleared or De Novo authorized test, and in compliance as described in section V.C.3 of the preamble to the LDT Final Rule, in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification as described in sections V.C.4 and V.C.5 of the preamble to the LDT Final Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCH. Product type: Ldt, Approved By Nys Clep. Official classification: Not classified. Official category: Unknown. Laboratory developed tests (LDTs) that are approved by the New York State Department of Health Clinical Laboratory Evaluation Program (NYS CLEP) described in section V.B.2 of the preamble to the LDT Final Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCI. Product type: Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule. Official classification: Not classified. Official category: Unknown. In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCJ. Product type: Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule. Official classification: Not classified. Official category: Unknown. Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B of the preamble to the LDT Final Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCK. Product type: Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd. Official classification: Not classified. Official category: Unknown. Non-molecular antisera laboratory developed tests (LDTs) for rare red blood cell (RBC) antigens when manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative in vitro diagnostic product (IVD) available to meet the patient's need for a compatible blood transfusion within the scope described in Section V.B.3 of the preamble to the Final LDT Rule (89 FR 37286). Implant flag: N. Life-sustain/support flag: N.

Official code: SCL. Product type: Allergen And Vaccine Delivery Needles. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5570. An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests. Implant flag: N. Life-sustain/support flag: N.

Official code: SCN. Product type: Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief. Official classification: Class II. Official category: Neurology. Regulation number: 882.5870. A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment. Implant flag: Y. Life-sustain/support flag: N.

Official code: SCP. Product type: Computerized Behavioral Therapy Device For Anxiety Disorders. Official classification: Class II. Official category: Neurology. Regulation number: 882.5801. Computerized behavioral therapy device for psychiatric disorders Implant flag: N. Life-sustain/support flag: N.

Official code: SCR. Product type: Air-Conduction Hearing Aid Software. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.3335. Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325. Implant flag: N. Life-sustain/support flag: N.

Official code: SCS. Product type: Ultraviolet Radiation Disinfection Chamber Device. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6511. An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation. Implant flag: N. Life-sustain/support flag: N.

Official code: SCT. Product type: Foley Catheters And Accessories With Additional Safety Features. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5130. Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections. Implant flag: N. Life-sustain/support flag: N.

Official code: SCU. Product type: Dna And Rna Oncology Controls. Official classification: Class II. Official category: Microbiology. Regulation number: 866.5910. Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls. Implant flag: N. Life-sustain/support flag: N.

Official code: SCV. Product type: Modular Electromechanical Surgical System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4964. A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: SCW. Product type: Digital Prismatic Correction. Official classification: Class I. Official category: Ophthalmic. Regulation number: 886.1655. The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction. Implant flag: N. Life-sustain/support flag: N.

Official code: SCX. Product type: Immunoassay For Host Biomarkers Of Sepsis. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3215. A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: SCY. Product type: Sacroiliac Joint Guidewire Placement Device. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3040. A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint. Implant flag: N. Life-sustain/support flag: N.

Official code: SCZ. Product type: Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1254. The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures. Implant flag: N. Life-sustain/support flag: N.

Official code: SDA. Product type: Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer. Official classification: Class III. Official category: Unknown. Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. Implant flag: N. Life-sustain/support flag: Y.

Official code: SDB. Product type: Tracheal Prosthesis With Cover Material Derived From Human Sources. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.3721. The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors. Implant flag: Y. Life-sustain/support flag: N.

Official code: SDC. Product type: Qualitative Cleaning Process Protein Indicator. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6930. A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract. Implant flag: N. Life-sustain/support flag: N.

Official code: SDD. Product type: Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4965. An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use. Implant flag: N. Life-sustain/support flag: N.

Official code: SDE. Product type: Light Based Device For Dry Age-Related Macular Degeneration. Official classification: Class II. Official category: Ophthalmic. Regulation number: 886.5520. A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration. Implant flag: N. Life-sustain/support flag: N.

Official code: SDG. Product type: Brain Intraparenchymal Infusion Cannula. Official classification: Class II. Official category: Neurology. Regulation number: 882.4110. A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: SDJ. Product type: Adjunctive Cardiac Amyloidosis Status Indicator. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2200. The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: SDK. Product type: Transdermal Test For Assessment Of Glomerular Filtration Rate. Official classification: Class III. Official category: Unknown. A test used to assess a patient’s glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor. Implant flag: N. Life-sustain/support flag: N.

Official code: SDL. Product type: Transvenous Temporary Phrenic Nerve Stimulator. Official classification: Class III. Official category: Unknown. The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older. Implant flag: N. Life-sustain/support flag: N.

Official code: SDM. Product type: Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. For the qualitative detection of infectious disease agents in human cadaveric (non-heart-beating) specimens Implant flag: N. Life-sustain/support flag: N.

Official code: SDN. Product type: Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens Implant flag: N. Life-sustain/support flag: N.

Official code: SDO. Product type: Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5851. A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit. Implant flag: N. Life-sustain/support flag: N.

Official code: SDP. Product type: Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit. Official classification: Class II. Official category: Hematology. Regulation number: 864.1861. A kappa and lambda immunoglobulin light chain in situ hybridization (ISH) mRNA probe is intended as an aid in the identification of hematolymphoid neoplasms using in situ hybridization. A Kappa and Lambda ISH mRNA probe cocktail is indicated for use when a hematolymphoid biopsy (e.g., bone marrow, lymphoid tissue) yields inconclusive results. The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms Implant flag: N. Life-sustain/support flag: N.

Official code: SDQ. Product type: Alfapump System. Official classification: Class III. Official category: Unknown. The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination. Implant flag: Y. Life-sustain/support flag: Y.

Official code: SDS. Product type: Compression-Based Airway Clearance Device. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5665. It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax. Implant flag: N. Life-sustain/support flag: N.

Official code: SDT. Product type: Intra-Pulmonary Percussive Vibration (Ipv) Devices. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5665. It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways. Implant flag: N. Life-sustain/support flag: N.

Official code: SDV. Product type: Clinical Electronic Thermometer. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2910. A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf Implant flag: N. Life-sustain/support flag: N.

Official code: SDW. Product type: Stationary Infrared Thermometer. Official classification: Class II. Official category: General Hospital. Regulation number: 880.2910. A stationary infrared thermometer is a free-standing or mounted clinical electronic thermometer indicated to measure a person’s body temperature. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf. Implant flag: N. Life-sustain/support flag: N.

Official code: SDX. Product type: Neuromuscular Stimulator And Exercise Evaluation System. Official classification: Class II. Official category: Neurology. Regulation number: 882.1871. A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions. Implant flag: N. Life-sustain/support flag: N.

Official code: SDY. Product type: Loss Of Pulse Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2790. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: SDZ. Product type: Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions. Official classification: Class III. Official category: Unknown. Endovascular Repair of Ascending Aorta and Aortic Arch Lesions Implant flag: Y. Life-sustain/support flag: N.

Official code: SEA. Product type: Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3386. This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use. Implant flag: N. Life-sustain/support flag: N.

Official code: SEC. Product type: Wearable Fall Injury Prevention Device. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.3780. A wearable fall injury prevention device is intended to detect falls and prevent major fall injuries. Once a fall is detected, the device deploys a protective mechanism to reduce the risk of injury. Implant flag: N. Life-sustain/support flag: N.

Official code: SEE. Product type: Computerized Behavioral Therapy Device For Migraine. Official classification: Class II. Official category: Neurology. Regulation number: 882.5806. A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache. Implant flag: N. Life-sustain/support flag: N.

Official code: SEF. Product type: Central Venous Catheter With Manual Insertion System. Official classification: Class II. Official category: General Hospital. Regulation number: 880.5200. A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel. Implant flag: N. Life-sustain/support flag: N.

Official code: SEG. Product type: Leadless Cardiac Resynchronization Therapy (Crt). Official classification: Class III. Official category: Unknown. Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant Implant flag: Y. Life-sustain/support flag: N.

Official code: SEI. Product type: Qualitative And Quantitative Hepatitis B Virus Antibody Assays. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3173. In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown. Implant flag: N. Life-sustain/support flag: N.

Official code: SEJ. Product type: Wound Dressings Containing Topical Analgesics. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain. Implant flag: N. Life-sustain/support flag: N.

Official code: SEK. Product type: Wound Dressings With Hydrocortisone. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound Implant flag: N. Life-sustain/support flag: N.

Official code: SEL. Product type: Securement Wound Dressing For Reduction Of Infection. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI). Implant flag: N. Life-sustain/support flag: N.

Official code: SEM. Product type: Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring. Official classification: Class II. Official category: Neurology. Regulation number: 882.1360. A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patient’s brain. The device is not intended to be implanted in brain tissue. Implant flag: Y. Life-sustain/support flag: N.

Official code: SEN. Product type: Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety. Official classification: Class II. Official category: Neurology. Regulation number: 882.5050. A biofeedback device for adjunctive treatment of patient-reported symptoms associated with stress and anxiety is intended to provide feedback to users with patient-reported symptoms associated with stress and anxiety on a physiological measurement as a relaxation treatment for the reduction of stress and anxiety. Implant flag: N. Life-sustain/support flag: N.

Official code: SEP. Product type: Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2920. A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated. Implant flag: N. Life-sustain/support flag: N.

Official code: SEQ. Product type: Covered Stent Vascular Connector, Hemodialysis Access Circuit. Official classification: Class III. Official category: Unknown. The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site. Implant flag: Y. Life-sustain/support flag: N.

Official code: SER. Product type: Immunohistochemistry Assay, Antibody, Met. Official classification: Class III. Official category: Hematology. Regulation number: 864.1860. The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: SES. Product type: Non-Factor Replacement Product Test System. Official classification: Class II. Official category: Hematology. Regulation number: 864.7298. A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling. Implant flag: N. Life-sustain/support flag: N.

Official code: SET. Product type: Immunoassay Blood Test For Amyloid Pathology Assessment. Official classification: Class II. Official category: Immunology. Regulation number: 866.5840. An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimer’s Disease who have signs and symptoms of cognitive decline. The results of the test are to be interpreted in conjunction with other patient clinical information. Implant flag: N. Life-sustain/support flag: N.

Official code: SEU. Product type: Peripheral Temporary And Retrievable Stent System. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.5110. A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: SEW. Product type: Automated Endoscope Channel Cleaner. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6994. An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization. Implant flag: N. Life-sustain/support flag: N.

Official code: SEZ. Product type: Radiological Software Device To Predict Future Breast Cancer Risk. Official classification: Class II. Official category: Radiology. Regulation number: 892.8500. A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patient’s future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams. Implant flag: N. Life-sustain/support flag: N.

Official code: SFA. Product type: Prosthesis, Finger, Semi-Constrained, Metal/Polymer. Official classification: Class III. Official category: Unknown. A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis. Implant flag: Y. Life-sustain/support flag: N.

Official code: SFC. Product type: Neurologic Disease Risk Assessment Molecular Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.5850. A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information. Implant flag: N. Life-sustain/support flag: N.

Official code: SFD. Product type: In Situ Polymerizing Peripheral Nerve Repair Device. Official classification: Class II. Official category: Neurology. Regulation number: 882.5270. An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries. Implant flag: Y. Life-sustain/support flag: N.

Official code: SFE. Product type: Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor. Implant flag: N. Life-sustain/support flag: N.

Official code: SFG. Product type: Camera, Surgical, Measurement. Official classification: Class I. Official category: General, Plastic Surgery. Regulation number: 878.4160. An adjunctive tool to measure and record a body part’s physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy. Implant flag: N. Life-sustain/support flag: N.

Official code: SFH. Product type: Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis. Official classification: Class II. Official category: Pathology. Regulation number: 864.3755. A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: SFI. Product type: Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System. Official classification: Class III. Official category: Unknown. The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA. Implant flag: N. Life-sustain/support flag: N.

Official code: SFJ. Product type: Vagus Nerve Stimulator For Rheumatoid Arthritis. Official classification: Class III. Official category: Unknown. Implantable vagus nerve stimulator for Rheumatoid Arthritis Implant flag: Y. Life-sustain/support flag: N.

Official code: SFK. Product type: Respiratory Effort Belt For Polysomnography. Official classification: Class II. Official category: Neurology. Regulation number: 882.1400. To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems. Implant flag: N. Life-sustain/support flag: N.

Official code: SFL. Product type: Nucleic Acid Based Assay, Microsatellite Instability. Official classification: Class III. Official category: Unknown. The microsatellite instability (MSI) companion diagnostic is nucleic acid based (molecular) in vitro diagnostic device intended for the qualitative detection of a panel of molecular biomarkers for identification of MSI in human clinical tissue specimens. It reports MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The MSI companion diagnostic is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess MSI status which may be associated with a better clinical response to specific FDA approved therapeutic drugs. Implant flag: N. Life-sustain/support flag: N.

Official code: SFN. Product type: Non-Invasive Evoked Response Brain Stimulator. Official classification: Class II. Official category: Neurology. Regulation number: 882.1860. A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response. Implant flag: N. Life-sustain/support flag: N.

Official code: SFO. Product type: Electrode Measurement, Drain Effluent Ph. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1120. Measurement of drain effluent pH Implant flag: N. Life-sustain/support flag: N.

Official code: SFP. Product type: Ventilator-Compatible Nebulizer. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5630. The device is intended to deliver nebulized medications through a ventilator breathing circuit. Implant flag: N. Life-sustain/support flag: N.

Official code: SFQ. Product type: Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4400. Surgical device used to dissect cardiac tissue for the implantation and revision of cardiac electrophysiology leads Implant flag: N. Life-sustain/support flag: N.

Official code: SFR. Product type: Hypertension Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SFS. Product type: Revumenib Eligibility Detection System. Official classification: Class II. Official category: Hematology. Regulation number: 864.1885. A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the purpose of identifying patients who may benefit from treatment with revumenib, in accordance with the approved therapeutic product labeling. Implant flag: N. Life-sustain/support flag: N.

Official code: SFU. Product type: Glucose Range Monitoring System. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1359. A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment. Implant flag: N. Life-sustain/support flag: N.

Official code: SFV. Product type: X-Ray, Computed Tomography, Cone-Beam. Official classification: Class II. Official category: Radiology. Regulation number: 892.1750. Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures. Implant flag: N. Life-sustain/support flag: N.

Official code: SFW. Product type: Cranial Electrotherapy Stimulator For Weight Management. Official classification: Class I. Official category: Gastroenterology, Urology. Regulation number: 876.5984. A cranial electrotherapy stimulator for weight management is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin to support weight management in conjunction with diet and exercise. Devices in this classification use a low level of electrical current that is not intended to induce a seizure. Implant flag: N. Life-sustain/support flag: N.

Official code: SGA. Product type: Biothreat Microbial Agent Nucleic Acid Detection Test. Official classification: Class II. Official category: Immunology. Regulation number: 866.4000. A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens. Implant flag: N. Life-sustain/support flag: N.

Official code: SGB. Product type: Pain Assessment Software In Non-Communicative Adults. Official classification: Class II. Official category: Neurology. Regulation number: 882.1472. Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool. Implant flag: N. Life-sustain/support flag: N.

Official code: SGD. Product type: Kit D816v Mutation Detection System. Official classification: HDE. Official category: Unknown. A KIT D816V mutation detection system is an in vitro diagnostic test intended for qualitative detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis using nucleic acid amplification and real time detection systems. The KIT D816V mutation detection system is indicated as an aid in the selection of aggressive systemic mastocytosis patients for whom Gleevec® (imatinib mesylate) treatment is being considered. Implant flag: N. Life-sustain/support flag: N.

Official code: SGE. Product type: Extracranial Positional System For A Transcranial Magnetic Stimulation System. Official classification: Class II. Official category: Neurology. Regulation number: 882.4560. Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system. Implant flag: N. Life-sustain/support flag: N.

Official code: SGF. Product type: Dural Arteriovenous Fistula Liquid Embolic. Official classification: HDE. Official category: Unknown. Indicated for use in the treatment of intracranial dural arteriovenous fistulas. Implant flag: Y. Life-sustain/support flag: N.

Official code: SGG. Product type: Mass Spectrometric, Immunoglobulins (G, A, M, D, E). Official classification: Class II. Official category: Immunology. Regulation number: 866.5510. The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods. Implant flag: N. Life-sustain/support flag: N.

Official code: SGH. Product type: Ultrasound Imaging For Vascular Access For Hemodialysis. Official classification: Class II. Official category: Radiology. Regulation number: 892.1560. Ultrasound imaging for vascular access for hemodialysis Implant flag: N. Life-sustain/support flag: N.

Official code: SGJ. Product type: Ultrasound Imaging System For Acquiring Images At Home By Lay Users. Official classification: Class II. Official category: Radiology. Regulation number: 892.1590. An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition. Implant flag: N. Life-sustain/support flag: N.

Official code: SGK. Product type: Prosthesis, Spinous Process Tension Band Implant. Official classification: Class III. Official category: Unknown. This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression. Implant flag: Y. Life-sustain/support flag: N.

Official code: SGL. Product type: Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4520. The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use. Implant flag: N. Life-sustain/support flag: N.

Official code: SGN. Product type: High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation. Official classification: Class II. Official category: Neurology. Regulation number: 882.4420. A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling. Implant flag: N. Life-sustain/support flag: N.

Official code: SGO. Product type: Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1254. The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure Implant flag: N. Life-sustain/support flag: N.

Official code: SGQ. Product type: Intraoral Phototherapy Device. Official classification: Class II. Official category: Dental. Regulation number: 872.5595. An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis. Implant flag: N. Life-sustain/support flag: N.

Official code: SGR. Product type: Noninvasive Positive Airway Pressure System, Facility Use. Official classification: Class II. Official category: Anesthesiology. Regulation number: 868.5895. To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure. Implant flag: N. Life-sustain/support flag: N.

Official code: SGS. Product type: Deep Brain Stimulation For The Treatment Of Dystonia. Official classification: Class III. Official category: Unknown. To stimulate deep brain structure to manage dystonia symptoms Implant flag: Y. Life-sustain/support flag: N.

Official code: SGT. Product type: Electromagnetic Stimulator For Healthy Muscle Stimulation. Official classification: Class II. Official category: Physical Medicine. Regulation number: 890.5850. A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: SGU. Product type: Neurovascular Liquid Embolic Agent. Official classification: Class III. Official category: Unknown. Arterial occlusion of the middle meningeal artery for treatment of symptomatic subdural hematoma. Implant flag: Y. Life-sustain/support flag: Y.

Official code: SGV. Product type: Agent, Absorbable Hemostatic, Collagen With Polymeric Additives. Official classification: Class III. Official category: General, Plastic Surgery. Regulation number: 878.4490. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. Implant flag: Y. Life-sustain/support flag: N.

Official code: SGW. Product type: Device To Detect Antibodies To Hepatitis D Virus. Official classification: Class II. Official category: Immunology. Regulation number: 866.3176. The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors. Implant flag: N. Life-sustain/support flag: N.

Official code: SGX. Product type: Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6512. An ultraviolet light-based microbial reduction device for luer-activated valves is a device that uses ultraviolet light to irradiate luer-activated valves (e.g., as used for intravascular administration). The device is intended to supplement the manual, physical microbicidal treatment of luer-activated valves by providing limited microbial reduction, and is not intended to disinfect or replace manual microbicidal treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: SGY. Product type: Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5881. A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit. Implant flag: N. Life-sustain/support flag: Y.

Official code: SGZ. Product type: Ultraviolet Lamp Products. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4635. An ultraviolet lamp product intended to stimulate the production of Vitamin D Implant flag: N. Life-sustain/support flag: N.

Official code: SHA. Product type: Solid Wound Dressing With Permanently Bound Antimicrobial Agent. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4013. A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls. Implant flag: N. Life-sustain/support flag: N.

Official code: SHB. Product type: Creatinine Test System For At Home Prescription Use. Official classification: Class II. Official category: Clinical Chemistry. Regulation number: 862.1225. For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only. Implant flag: N. Life-sustain/support flag: N.

Official code: SHC. Product type: Low Electric Field Generator For Pancreatic Cancer Treatment. Official classification: Class III. Official category: Unknown. Intended to treat pancreatic cancer through delivery of low electric fields in patients receiving concomitant systemic therapies or other standard of care treatment(s) Implant flag: N. Life-sustain/support flag: Y.

Official code: SHE. Product type: Radiological Software System For Delivery Date Prediction. Official classification: Class II. Official category: Radiology. Regulation number: 892.8200. A radiological software system for delivery date prediction is a software-only device that analyzes obstetric radiological images to predict the delivery date of a pregnancy. The device output does not replace a clinician's review or judgment on the progression of a pregnancy and should be used in conjunction with other clinical and diagnostic findings. The device does not identify at-risk pregnancies or identify specific complications. Implant flag: N. Life-sustain/support flag: N.

Official code: SHH. Product type: Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer. Official classification: Class III. Official category: Unknown. Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy). Implant flag: N. Life-sustain/support flag: N.

Official code: SHI. Product type: Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter. Official classification: Class II. Official category: Dental. Regulation number: 872.3660. An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards. Implant flag: N. Life-sustain/support flag: N.

Official code: SHL. Product type: Ear, Nose, And Throat Image Analyzer. Official classification: Class II. Official category: Ear, Nose, Throat. Regulation number: 874.4775. An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: SHM. Product type: Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe. Official classification: Class II. Official category: General Hospital. Regulation number: 880.6891. An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. “Safe to handle” is limited in scope to mean the device has been appropriately intermediate-level disinfected. Implant flag: N. Life-sustain/support flag: N.

Official code: SHN. Product type: Calibration Software For Radiology Displays. Official classification: Class I. Official category: Radiology. Regulation number: 892.1940. The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology. Implant flag: N. Life-sustain/support flag: N.

Official code: SHO. Product type: Parkinsonian Syndrome Diagnostic Aid. Official classification: Class II. Official category: Neurology. Regulation number: 882.2000. A Parkinsonian syndrome diagnostic aid is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. This device is intended for adjunctive use and not intended as a stand-alone diagnostic. Implant flag: N. Life-sustain/support flag: N.

Official code: SHP. Product type: Cardiac Amyloidosis Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SHQ. Product type: Dental Image Analyzer, In-Office. Official classification: Class II. Official category: Dental. Regulation number: 872.1770. A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions. Implant flag: N. Life-sustain/support flag: N.

Official code: SHR. Product type: Device For Open Surgical Explant Of Endovascular Prostheses. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.4520. This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels. Implant flag: N. Life-sustain/support flag: N.

Official code: SHU. Product type: Appendiceal Scope And Accessories, Flexible. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.1500. Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall. Implant flag: N. Life-sustain/support flag: N.

Official code: SHV. Product type: Reusable Intermittent Urinary Catheter System. Official classification: Class II. Official category: Gastroenterology, Urology. Regulation number: 876.5120. A reusable intermittent urinary catheter system consists of a reusable intermittent urinary catheter inserted through the urethra into the bladder for urine drainage and the components necessary to reprocess the intermittent catheter. The reusable intermittent urinary catheter can be reused after reprocessing (e.g., cleaning and disinfection) with the components necessary to reprocess the intermittent catheter. The system may include cleaning and microbicidal agents, lubricant and disposable components. The reusable intermittent catheter and any reusable reprocessing components are intended for single patient reuse. Implant flag: N. Life-sustain/support flag: N.

Official code: SHW. Product type: Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis. Official classification: Class II. Official category: Pathology. Regulation number: 864.3755. A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from breast cancer specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis. Implant flag: N. Life-sustain/support flag: N.

Official code: SHX. Product type: Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms. Official classification: Class II. Official category: Neurology. Regulation number: 882.5807. A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s head. The device is not intended as a stand-alone therapy or to alter usual care treatment. Implant flag: N. Life-sustain/support flag: N.

Official code: SHY. Product type: Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.1840. A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device. Implant flag: N. Life-sustain/support flag: N.

Official code: SIA. Product type: Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test. Official classification: Class II. Official category: Microbiology. Regulation number: 866.3984. An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments. Implant flag: N. Life-sustain/support flag: N.

Official code: SIB. Product type: Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic. Official classification: Not classified. Official category: Unknown. TEMPO Pilot: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes) Implant flag: N. Life-sustain/support flag: N.

Official code: SIC. Product type: Tempo Pilot Ckm: Cardio-Kidney-Metabolic. Official classification: Not classified. Official category: Unknown. TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease) Implant flag: N. Life-sustain/support flag: N.

Official code: SID. Product type: Tempo Pilot Msk: Musculoskeletal. Official classification: Not classified. Official category: Unknown. TEMPO Pilot: musculoskeletal (chronic musculoskeletal pain) Implant flag: N. Life-sustain/support flag: N.

Official code: SIE. Product type: Tempo Pilot Bh: Behavioral Health. Official classification: Not classified. Official category: Unknown. TEMPO Pilot: behavioral health (depression or anxiety) Implant flag: N. Life-sustain/support flag: N.

Official code: SIF. Product type: Software Device System For Estimation Of Cardiac Pressures. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.1150. This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure. Implant flag: N. Life-sustain/support flag: N.

Official code: SIG. Product type: Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd). Official classification: Class II. Official category: Neurology. Regulation number: 882.5802. External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields in brain areas outside cerebral cortex (e.g., cerebellum). Implant flag: N. Life-sustain/support flag: N.

Official code: SIH. Product type: Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay. Official classification: Class II. Official category: Microbiology. Regulation number: 866.2920. A device for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay is a device intended for use by lay users in home settings or similar environments for the collection and transportation of specimens for testing using a cleared non-viral STI molecular assay with which the device has been validated. Implant flag: N. Life-sustain/support flag: N.

Official code: SII. Product type: Aortic Stenosis Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Aortic Stenosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of aortic stenosis for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SIJ. Product type: Valvular Regurgitation Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Valvular regurgitation machine learning-based notification software employs machine learning techniques to suggest the likelihood of valvular regurgitation for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SIK. Product type: Cardiac Hypertrophy Machine Learning-Based Notification Software. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2380. Cardiac hypertrophy machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac hypertrophy for further referral or diagnostic follow-up. Implant flag: N. Life-sustain/support flag: N.

Official code: SIL. Product type: Wound Dressings Containing Oxygen. Official classification: Unclassified (FDA reason code 1). Official category: Unknown. A wound dressing containing oxygen is intended to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound. Implant flag: N. Life-sustain/support flag: N.

Official code: SIM. Product type: Gynecologic Power Morcellator And Containment System. Official classification: Class II. Official category: Obstetrics/Gynecology. Regulation number: 884.4075. A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery. Implant flag: N. Life-sustain/support flag: N.

Official code: SIN. Product type: Automated Intraoperative Spinal Rod Bending System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.3070. A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod. Implant flag: N. Life-sustain/support flag: N.

Official code: SIO. Product type: Test For Esophageal Varices. Official classification: Class III. Official category: Unknown. A Test for Esophageal Varices is a quantitative test that measures cholate concentrations in human specimens and uses the cholate concentrations to generate a score. The score is used to identify patients unlikely to have large esophageal varices and unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing. Implant flag: N. Life-sustain/support flag: N.

Official code: SIQ. Product type: Intra-Articular Orthopedic Stereotaxic Navigation Instrument. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.4561. An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices. Implant flag: N. Life-sustain/support flag: N.

Official code: SIR. Product type: Integrated Operating Table-Electromechanical Surgical System. Official classification: Class II. Official category: General, Plastic Surgery. Regulation number: 878.4966. An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform. Implant flag: N. Life-sustain/support flag: N.

Official code: SIT. Product type: Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System. Official classification: Class II. Official category: Orthopedic. Regulation number: 888.1150. This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices. Implant flag: N. Life-sustain/support flag: N.

Official code: SIU. Product type: Predictive Indicator For Long-Term Cardiovascular Outcomes. Official classification: Class II. Official category: Cardiovascular. Regulation number: 870.2215. The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease. Implant flag: N. Life-sustain/support flag: N.

Official code: SIX. Product type: Digital Pathology Image Artifact Detection Software Device. Official classification: Class II. Official category: Pathology. Regulation number: 864.3700. Digital Pathology Image Artifact Detection Software device is an artificial intelligence-based software intended to identify specific artifacts in scanned digital whole slide images (WSIs) of pathology slides prepared from human samples. It is intended to identify WSIs that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Device output is not intended for use in diagnosis, prognosis, or prediction of disease. Implant flag: N. Life-sustain/support flag: N.